High-dose Prophylactic Gabapentin (HOPE) vs. Placebo to Prevent Opioid Use for Oral Mucositis Pain During Concurrent Chemoradiation for Head and Neck Cancer (HOPE)

May 7, 2026 updated by: Alliance for Clinical Trials in Oncology

High-Dose Prophylactic Gabapentin (HOPE) to Prevent Opioid Use for Oral Mucositis Pain During Head and Neck Chemoradiotherapy: A Phase III Clinical Trial

This phase III trial tests if gabapentin can prevent the need for opiate pain medication for mouth sores (oral mucositis) in patients undergoing treatment with chemotherapy and radiation for squamous cell carcinoma of the head and neck region. Oral mucositis is a common side effect of radiation treatment and can cause severe pain, dysphagia, and weight loss resulting in feeding tube placement, worse health-related quality of life, treatment interruptions, unplanned hospitalizations, and significant financial burden. Mucositis pain is often treated with opioid pain medications which do provide pain relief but have many known side effects not limited to mental clouding, constipation, fatigue, endocrinopathy, neurotoxicity, sleep-disordered breathing, and most distressingly persistent opioid use. Gabapentin may help relieve pain from oral mucositis caused by radiation while also reducing the need for opiate pain medications for patients receiving chemotherapy and radiation for squamous cell carcinoma of the head and neck region

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVE:

I. To determine whether prophylactic high dose gabapentin, titrated to a dose of 3600 mg (1200 mg three times per day [TID]), is superior to placebo in increasing the proportion of patients not needing opiates while undergoing chemoradiation therapy.

SECONDARY OBJECTIVES:

I. To determine whether prophylactic high dose gabapentin is superior to placebo in prolonging the time to first opioid use while undergoing chemoradiation therapy.

II. To determine whether prophylactic high dose gabapentin is superior to placebo in improving patient reported pain scores using the 0-10 numerical rating scale (NRS) from baseline to 4 weeks after the end of chemoradiation therapy.

EXPLORATORY OBJECTIVES:

I. To explore the duration of opioid use from the time of initiation to cessation by arm as well as describe the proportion of patients remaining on opioids at 3 months, 6 months, and 1 year by arm.

II. To explore the trajectory of patient reported symptom and quality of life outcomes using the Oral Mucositis Weekly Questionnaire (OMWQ) by arm.

III. To explore the trajectory of patient reported symptom and quality of life outcomes using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-30 (EORTC QLQ-30) by arm.

IV. To explore the trajectory of patient reported symptom and quality of life outcomes using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck-43 (EORTC QLQ-H&N43) by arm.

V. To evaluate the adverse event profiles of prophylactic high dose gabapentin versus placebo.

VI. To assess the tolerance of high dose gabapentin. VII. To explore the trajectory of patient health using patient body mass index (BMI) and creatinine, absolute neutrophil count (ANC) as routinely obtained by arm.

VIII. To describe the incidence of feeding tube requirement during and after chemoradiation therapy by arm.

IX. To describe the dose of prescribed opioids standardized using the Morphine Milligram Equivalent calculator by arm.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Starting by radiation treatment 8, patients receive placebo orally (PO) once daily (QD) on day 1, twice daily (BID) on day 2, then three times daily (TID) starting day 3 onward. Patients also receive standard of care radiation, chemotherapy and pain medications. Treatment with placebo continues in the absence of disease progression or unacceptable toxicity, until the symptoms of oral mucositis and other treatment effects begin to resolve and other pain medications has been stopped. Patients then continue to receive placebo TID for 9 additional days, at sequentially smaller doses, then BID for 1 day and QD for one day before stopping. Patients undergo blood sample collection throughout the study.

ARM II: Starting by radiation treatment 8, patients receive gabapentin PO QD on day 1, BID on day 2, then TID starting day 3 onward. Patients also receive standard of care radiation, chemotherapy and pain medications. Treatment with gabapentin continues in the absence of disease progression or unacceptable toxicity, until the symptoms of oral mucositis and other treatment effects begin to resolve and other pain medications has been stopped. Patients then continue to receive gabapentin TID for 9 additional days, at sequentially smaller doses, then BID for 1 day and QD for one day before stopping. Patients undergo blood sample collection throughout the study.

After completion of study treatment, patients are followed up at 4 weeks, 3 months and 6 months after the last dose of chemoradiation therapy.

Study Type

Interventional

Enrollment (Estimated)

228

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arizona
      • Gilbert, Arizona, United States, 85297
        • Recruiting
        • Arizona Center for Cancer Care - Gilbert
        • Contact:
        • Principal Investigator:
          • Cory W. Heal
      • Peoria, Arizona, United States, 85381
        • Recruiting
        • Arizona Center for Cancer Care-Peoria
        • Contact:
          • Site Public Contact
          • Phone Number: 623-773-2873
        • Principal Investigator:
          • Cory W. Heal
      • Phoenix, Arizona, United States, 85027
        • Recruiting
        • Arizona Center for Cancer Care - Phoenix
        • Contact:
        • Principal Investigator:
          • Cory W. Heal
      • Phoenix, Arizona, United States, 85016
        • Recruiting
        • Arizona Center for Cancer Care - Biltmore
        • Contact:
        • Principal Investigator:
          • Cory W. Heal
      • Scottsdale, Arizona, United States, 85251
        • Recruiting
        • Arizona Center for Cancer Care - Osborn
        • Contact:
        • Principal Investigator:
          • Cory W. Heal
      • Scottsdale, Arizona, United States, 85258
        • Recruiting
        • Arizona Center for Cancer Care - Scottsdale
        • Contact:
        • Principal Investigator:
          • Cory W. Heal
      • Surprise, Arizona, United States, 85374
        • Recruiting
        • Arizona Center for Cancer Care-Surprise
        • Contact:
        • Principal Investigator:
          • Cory W. Heal
      • Tempe, Arizona, United States, 85284
        • Recruiting
        • Arizona Center for Cancer Care
        • Contact:
        • Principal Investigator:
          • Cory W. Heal
    • California
      • Bakersfield, California, United States, 93301
        • Recruiting
        • AIS Cancer Center at San Joaquin Community Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 661-323-4673
        • Principal Investigator:
          • Luis Mariscal
      • Dublin, California, United States, 94568
        • Active, not recruiting
        • Kaiser Permanente Dublin
      • Fremont, California, United States, 94538
        • Active, not recruiting
        • Kaiser Permanente-Fremont
      • Fresno, California, United States, 93720
        • Active, not recruiting
        • Kaiser Permanente Fresno Orchard Plaza
      • Los Angeles, California, United States, 90033
        • Recruiting
        • USC / Norris Comprehensive Cancer Center
        • Principal Investigator:
          • Adam Garsa
        • Contact:
          • Site Public Contact
          • Phone Number: 323-865-0451
      • Los Angeles, California, United States, 90033
        • Recruiting
        • Los Angeles General Medical Center
        • Principal Investigator:
          • Adam Garsa
        • Contact:
      • Modesto, California, United States, 95356
        • Active, not recruiting
        • Kaiser Permanente-Modesto
      • Modesto, California, United States, 95356
        • Active, not recruiting
        • Kaiser Permanente- Modesto MOB II
      • Oakland, California, United States, 94611
        • Active, not recruiting
        • Kaiser Permanente-Oakland
      • Roseville, California, United States, 95661
        • Active, not recruiting
        • Kaiser Permanente-Roseville
      • Sacramento, California, United States, 95823
        • Active, not recruiting
        • Kaiser Permanente-South Sacramento
      • Sacramento, California, United States, 95814
        • Active, not recruiting
        • Kaiser Permanente Downtown Commons
      • San Francisco, California, United States, 94115
        • Active, not recruiting
        • Kaiser Permanente-San Francisco
      • San Jose, California, United States, 95119
        • Active, not recruiting
        • Kaiser Permanente-Santa Teresa-San Jose
      • San Leandro, California, United States, 94577
        • Active, not recruiting
        • Kaiser Permanente San Leandro
      • San Rafael, California, United States, 94903
        • Active, not recruiting
        • Kaiser San Rafael-Gallinas
      • Santa Clara, California, United States, 95051
        • Active, not recruiting
        • Kaiser Permanente Medical Center - Santa Clara
      • Santa Rosa, California, United States, 95403
        • Active, not recruiting
        • Kaiser Permanente-Santa Rosa
      • South San Francisco, California, United States, 94080
        • Active, not recruiting
        • Kaiser Permanente-South San Francisco
      • Vallejo, California, United States, 94589
        • Active, not recruiting
        • Kaiser Permanente-Vallejo
      • Walnut Creek, California, United States, 94596
        • Active, not recruiting
        • Kaiser Permanente-Walnut Creek
    • Colorado
      • Denver, Colorado, United States, 80205
        • Recruiting
        • Kaiser Permanente-Franklin
        • Principal Investigator:
          • Matthew J. Eadens
        • Contact:
      • Lafayette, Colorado, United States, 80026
        • Recruiting
        • Kaiser Permanente-Rock Creek
        • Principal Investigator:
          • Matthew J. Eadens
        • Contact:
      • Lakewood, Colorado, United States, 80228
    • Hawaii
      • Honolulu, Hawaii, United States, 96819
        • Active, not recruiting
        • Kaiser Permanente Moanalua Medical Center
    • Idaho
      • Boise, Idaho, United States, 83712
        • Recruiting
        • Saint Luke's Cancer Institute - Boise
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Coeur d'Alene, Idaho, United States, 83814
        • Recruiting
        • Kootenai Health - Coeur d'Alene
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Fruitland, Idaho, United States, 83619
        • Recruiting
        • Saint Luke's Cancer Institute - Fruitland
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Meridian, Idaho, United States, 83642
        • Recruiting
        • Saint Luke's Cancer Institute - Meridian
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Nampa, Idaho, United States, 83687
        • Recruiting
        • Saint Luke's Cancer Institute - Nampa
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Post Falls, Idaho, United States, 83854
        • Recruiting
        • Kootenai Clinic Cancer Services - Post Falls
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Sandpoint, Idaho, United States, 83864
        • Recruiting
        • Kootenai Clinic Cancer Services - Sandpoint
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
    • Illinois
      • Aurora, Illinois, United States, 60506
        • Recruiting
        • Advocate Outpatient Center - Aurora
        • Principal Investigator:
          • Thomas J. Saphner
        • Contact:
      • Aurora, Illinois, United States, 60504
        • Suspended
        • Rush-Copley Medical Center
      • Barrington, Illinois, United States, 60010
        • Recruiting
        • Advocate Good Shepherd Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 847-842-4847
        • Principal Investigator:
          • Thomas J. Saphner
      • Bloomington, Illinois, United States, 61704
        • Recruiting
        • Illinois CancerCare-Bloomington
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Canton, Illinois, United States, 61520
        • Recruiting
        • Illinois CancerCare-Canton
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Carthage, Illinois, United States, 62321
        • Recruiting
        • Illinois CancerCare-Carthage
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Chicago, Illinois, United States, 60657
        • Recruiting
        • Advocate Illinois Masonic Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 773-296-5360
        • Principal Investigator:
          • Thomas J. Saphner
      • Crystal Lake, Illinois, United States, 60014
        • Recruiting
        • AMG Crystal Lake - Oncology
        • Contact:
        • Principal Investigator:
          • Thomas J. Saphner
      • Danville, Illinois, United States, 61832
        • Suspended
        • Carle at The Riverfront
      • Decatur, Illinois, United States, 62526
        • Recruiting
        • Cancer Care Specialists of Illinois - Decatur
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Decatur, Illinois, United States, 62526
        • Recruiting
        • Decatur Memorial Hospital
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Dixon, Illinois, United States, 61021
        • Recruiting
        • Illinois CancerCare-Dixon
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 815-285-7800
      • Downers Grove, Illinois, United States, 60515
        • Recruiting
        • Advocate Good Samaritan Hospital
        • Contact:
        • Principal Investigator:
          • Thomas J. Saphner
      • Effingham, Illinois, United States, 62401
        • Recruiting
        • Crossroads Cancer Center
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Effingham, Illinois, United States, 62401
        • Suspended
        • Carle Physician Group-Effingham
      • Elgin, Illinois, United States, 60123
        • Recruiting
        • Advocate Sherman Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 847-429-2907
        • Principal Investigator:
          • Thomas J. Saphner
      • Eureka, Illinois, United States, 61530
        • Recruiting
        • Illinois CancerCare-Eureka
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Galesburg, Illinois, United States, 61401
        • Recruiting
        • Illinois CancerCare-Galesburg
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Hazel Crest, Illinois, United States, 60429
        • Recruiting
        • Advocate South Suburban Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 708-799-9995
        • Principal Investigator:
          • Thomas J. Saphner
      • Kewanee, Illinois, United States, 61443
        • Recruiting
        • Illinois CancerCare-Kewanee Clinic
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Libertyville, Illinois, United States, 60048
        • Recruiting
        • AMG Libertyville - Oncology
        • Contact:
        • Principal Investigator:
          • Thomas J. Saphner
      • Libertyville, Illinois, United States, 60048
        • Recruiting
        • Condell Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Thomas J. Saphner
      • Macomb, Illinois, United States, 61455
        • Recruiting
        • Illinois CancerCare-Macomb
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Mattoon, Illinois, United States, 61938
        • Suspended
        • Carle Physician Group-Mattoon/Charleston
      • Moline, Illinois, United States, 61265
        • Suspended
        • Trinity Medical Center
      • Normal, Illinois, United States, 61761
        • Suspended
        • Carle Cancer Institute Normal
      • Normal, Illinois, United States, 61761
        • Suspended
        • Carle BroMenn Medical Center
      • O'Fallon, Illinois, United States, 62269
        • Recruiting
        • Cancer Care Center of O'Fallon
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • O'Fallon, Illinois, United States, 62269
        • Recruiting
        • HSHS Saint Elizabeth's Hospital
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Oak Lawn, Illinois, United States, 60453-2699
        • Recruiting
        • Advocate Christ Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 800-323-8622
        • Principal Investigator:
          • Thomas J. Saphner
      • Oak Lawn, Illinois, United States, 60453
        • Recruiting
        • Advocate Outpatient Center - Oak Lawn
        • Principal Investigator:
          • Thomas J. Saphner
        • Contact:
      • Ottawa, Illinois, United States, 61350
        • Recruiting
        • Illinois CancerCare-Ottawa Clinic
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Palos Heights, Illinois, United States, 60463
        • Recruiting
        • Advocate High Tech Medical Park
        • Principal Investigator:
          • Thomas J. Saphner
        • Contact:
      • Park Ridge, Illinois, United States, 60068
        • Recruiting
        • Advocate Lutheran General Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 847-384-3621
        • Principal Investigator:
          • Thomas J. Saphner
      • Pekin, Illinois, United States, 61554
        • Recruiting
        • Illinois CancerCare-Pekin
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Peoria, Illinois, United States, 61615
        • Recruiting
        • Illinois CancerCare-Peoria
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Peru, Illinois, United States, 61354
        • Recruiting
        • Illinois CancerCare-Peru
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Princeton, Illinois, United States, 61356
        • Recruiting
        • Illinois CancerCare-Princeton
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Springfield, Illinois, United States, 62702
        • Recruiting
        • Southern Illinois University School of Medicine
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 217-545-7929
      • Springfield, Illinois, United States, 62702
        • Recruiting
        • Springfield Clinic
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 800-444-7541
      • Springfield, Illinois, United States, 62781
        • Recruiting
        • Springfield Memorial Hospital
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Urbana, Illinois, United States, 61801
        • Suspended
        • Carle Cancer Center
      • Washington, Illinois, United States, 61571
        • Recruiting
        • Illinois CancerCare - Washington
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
    • Iowa
      • Ames, Iowa, United States, 50010
        • Recruiting
        • Mary Greeley Medical Center
        • Principal Investigator:
          • Joseph J. Merchant
        • Contact:
          • Site Public Contact
          • Phone Number: 515-956-4132
      • Ames, Iowa, United States, 50010
        • Recruiting
        • McFarland Clinic - Ames
        • Principal Investigator:
          • Joseph J. Merchant
        • Contact:
      • Boone, Iowa, United States, 50036
        • Suspended
        • McFarland Clinic - Boone
      • Cedar Rapids, Iowa, United States, 52403
        • Recruiting
        • Mercy Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 319-365-4673
        • Principal Investigator:
          • Deborah W. Wilbur
      • Cedar Rapids, Iowa, United States, 52403
        • Recruiting
        • Oncology Associates at Mercy Medical Center
        • Principal Investigator:
          • Deborah W. Wilbur
        • Contact:
          • Site Public Contact
          • Phone Number: 319-363-2690
      • Cedar Rapids, Iowa, United States, 52402
        • Recruiting
        • Saint Luke's Hospital
        • Contact:
        • Principal Investigator:
          • Candace R. Correa
      • Council Bluffs, Iowa, United States, 51503
        • Suspended
        • Methodist Jennie Edmundson Hospital
      • Fort Dodge, Iowa, United States, 50501
        • Recruiting
        • McFarland Clinic - Trinity Cancer Center
        • Principal Investigator:
          • Joseph J. Merchant
        • Contact:
          • Site Public Contact
          • Phone Number: 515-956-4132
      • Jefferson, Iowa, United States, 50129
        • Suspended
        • McFarland Clinic - Jefferson
      • Marshalltown, Iowa, United States, 50158
        • Recruiting
        • McFarland Clinic - Marshalltown
        • Principal Investigator:
          • Joseph J. Merchant
        • Contact:
          • Site Public Contact
          • Phone Number: 515-956-4132
    • Maine
      • Augusta, Maine, United States, 04330
        • Recruiting
        • Harold Alfond Center for Cancer Care
        • Principal Investigator:
          • Vatche Tchekmedyian
        • Contact:
          • Site Public Contact
          • Phone Number: 207-626-4855
      • Bath, Maine, United States, 04530
        • Recruiting
        • MaineHealth Coastal Cancer Treatment Center
        • Principal Investigator:
          • Vatche Tchekmedyian
        • Contact:
      • Brunswick, Maine, United States, 04011
        • Recruiting
        • MaineHealth Cancer Care and IV Therapy - Brunswick
        • Principal Investigator:
          • Vatche Tchekmedyian
        • Contact:
      • Damariscotta, Maine, United States, 04543
        • Recruiting
        • MaineHealth LincolnHealth Hospital
        • Principal Investigator:
          • Vatche Tchekmedyian
        • Contact:
      • Portland, Maine, United States, 04102
        • Recruiting
        • MaineHealth Maine Medical Center - Portland
        • Principal Investigator:
          • Vatche Tchekmedyian
        • Contact:
      • Sanford, Maine, United States, 04073
        • Recruiting
        • MaineHealth Cancer Care Center of York County
        • Principal Investigator:
          • Vatche Tchekmedyian
        • Contact:
          • Site Public Contact
          • Phone Number: 207-459-1600
      • Scarborough, Maine, United States, 04074
        • Recruiting
        • MaineHealth Maine Medical Center- Scarborough
        • Principal Investigator:
          • Vatche Tchekmedyian
        • Contact:
      • South Portland, Maine, United States, 04106
        • Recruiting
        • MaineHealth Cancer Care and IV Therapy - South Portland
        • Principal Investigator:
          • Vatche Tchekmedyian
        • Contact:
    • Minnesota
      • Bemidji, Minnesota, United States, 56601
      • Saint Cloud, Minnesota, United States, 56303
        • Recruiting
        • Coborn Cancer Center at Saint Cloud Hospital
        • Contact:
        • Principal Investigator:
          • Donald J. Jurgens
    • Missouri
      • Cape Girardeau, Missouri, United States, 63703
        • Recruiting
        • Saint Francis Medical Center
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 573-334-2230
          • Email: sfmc@sfmc.net
      • Joplin, Missouri, United States, 64804
        • Recruiting
        • Freeman Health System
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • St Louis, Missouri, United States, 63128
        • Recruiting
        • Mercy Hospital South
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • St Louis, Missouri, United States, 63141
        • Recruiting
        • Mercy Hospital Saint Louis
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 314-251-7066
    • Montana
      • Anaconda, Montana, United States, 59711
        • Recruiting
        • Community Hospital of Anaconda
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Billings, Montana, United States, 59101
        • Recruiting
        • Billings Clinic Cancer Center
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Bozeman, Montana, United States, 59715
        • Recruiting
        • Bozeman Health Deaconess Hospital
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Great Falls, Montana, United States, 59405
        • Recruiting
        • Benefis Sletten Cancer Institute
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Kalispell, Montana, United States, 59901
        • Recruiting
        • Logan Health Medical Center
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Missoula, Montana, United States, 59804
        • Recruiting
        • Community Medical Center
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
    • Nebraska
      • Bellevue, Nebraska, United States, 68123
        • Recruiting
        • Nebraska Medicine-Bellevue
        • Contact:
        • Principal Investigator:
          • Weining Zhen
      • Kearney, Nebraska, United States, 68847
        • Suspended
        • CHI Health Good Samaritan
      • Omaha, Nebraska, United States, 68198
        • Recruiting
        • University of Nebraska Medical Center
        • Contact:
        • Principal Investigator:
          • Weining Zhen
      • Omaha, Nebraska, United States, 68114
        • Recruiting
        • Nebraska Methodist Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 402-354-5144
        • Principal Investigator:
          • Tien-Shew W. Huang
      • Omaha, Nebraska, United States, 68118
        • Recruiting
        • Nebraska Medicine-Village Pointe
        • Contact:
          • Site Public Contact
          • Phone Number: 402-559-5600
        • Principal Investigator:
          • Weining Zhen
    • New Jersey
      • Cherry Hill, New Jersey, United States, 08002
        • Recruiting
        • Jefferson Cherry Hill Hospital
        • Principal Investigator:
          • Voichita Bar Ad
        • Contact:
      • Sewell, New Jersey, United States, 08080
        • Recruiting
        • Sidney Kimmel Cancer Center Washington Township
        • Principal Investigator:
          • Voichita Bar Ad
        • Contact:
    • New York
      • Buffalo, New York, United States, 14263
        • Recruiting
        • Roswell Park Cancer Institute
        • Contact:
        • Principal Investigator:
          • Anurag K. Singh
      • Forest Hills, New York, United States, 11375
        • Recruiting
        • Northwell Health Physicians Partners Radiation Medicine at Queens
        • Principal Investigator:
          • Bhupesh Parashar
        • Contact:
          • Site Public Contact
          • Phone Number: 718-520-6620
      • Lake Success, New York, United States, 11042
        • Recruiting
        • Northwell Health/Center for Advanced Medicine
        • Principal Investigator:
          • Bhupesh Parashar
        • Contact:
          • Site Public Contact
          • Phone Number: 516-734-8896
      • New York, New York, United States, 10075
        • Recruiting
        • Lenox Hill Hospital
        • Principal Investigator:
          • Bhupesh Parashar
        • Contact:
          • Site Public Contact
          • Phone Number: 516-734-8896
      • New York, New York, United States, 10065
        • Recruiting
        • Manhattan Eye Ear and Throat Hospital
        • Principal Investigator:
          • Bhupesh Parashar
        • Contact:
          • Site Public Contact
          • Phone Number: 212-434-4460
      • Rego Park, New York, United States, 11374
        • Recruiting
        • Queens Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 718-312-3446
        • Principal Investigator:
          • Bhupesh Parashar
      • Stony Brook, New York, United States, 11794
        • Recruiting
        • Stony Brook University Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 800-862-2215
        • Principal Investigator:
          • Kartik M. Mani
      • The Bronx, New York, United States, 10461
        • Recruiting
        • Montefiore Medical Center-Einstein Campus
        • Contact:
        • Principal Investigator:
          • Rafi Kabarriti
      • The Bronx, New York, United States, 10467
        • Recruiting
        • Montefiore Medical Center - Moses Campus
        • Contact:
        • Principal Investigator:
          • Rafi Kabarriti
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
      • Fargo, North Dakota, United States, 58122
      • Fargo, North Dakota, United States, 58122
    • Ohio
      • Canton, Ohio, United States, 44710
        • Recruiting
        • Aultman Health Foundation
        • Contact:
        • Principal Investigator:
          • Jessica L. Wobb
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • University of Oklahoma Health Sciences Center
        • Contact:
        • Principal Investigator:
          • Christina Henson
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822
        • Recruiting
        • Geisinger Medical Center
        • Contact:
        • Principal Investigator:
          • Fiori Alite
      • Dickson City, Pennsylvania, United States, 18519
        • Recruiting
        • Geisinger Cancer Center Dickson City
        • Principal Investigator:
          • Fiori Alite
        • Contact:
      • Erie, Pennsylvania, United States, 16505
        • Recruiting
        • UPMC Hillman Cancer Center Erie
        • Principal Investigator:
          • Dan P. Zandberg
        • Contact:
      • Erie, Pennsylvania, United States, 16544
        • Recruiting
        • Saint Vincent Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 814-452-5000
        • Principal Investigator:
          • Larisa Greenberg
      • Farrell, Pennsylvania, United States, 16121
        • Recruiting
        • UPMC Cancer Center at UPMC Horizon
        • Contact:
        • Principal Investigator:
          • Dan P. Zandberg
      • Greensburg, Pennsylvania, United States, 15601
        • Recruiting
        • UPMC Cancer Centers - Arnold Palmer Pavilion
        • Contact:
          • Site Public Contact
          • Phone Number: 724-838-1900
        • Principal Investigator:
          • Dan P. Zandberg
      • Harrisburg, Pennsylvania, United States, 17109
        • Recruiting
        • UPMC Pinnacle Cancer Center/Community Osteopathic Campus
        • Contact:
        • Principal Investigator:
          • Dan P. Zandberg
      • Jefferson Hills, Pennsylvania, United States, 15025
        • Recruiting
        • Jefferson Hospital
        • Contact:
        • Principal Investigator:
          • Larisa Greenberg
      • Lewisburg, Pennsylvania, United States, 17837
        • Recruiting
        • Geisinger Medical Oncology-Lewisburg
        • Contact:
        • Principal Investigator:
          • Fiori Alite
      • Mechanicsburg, Pennsylvania, United States, 17050
        • Recruiting
        • UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
        • Contact:
        • Principal Investigator:
          • Dan P. Zandberg
      • Monroeville, Pennsylvania, United States, 15146
        • Recruiting
        • Forbes Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 412-858-7746
        • Principal Investigator:
          • Larisa Greenberg
      • Monroeville, Pennsylvania, United States, 15146
        • Recruiting
        • UPMC Hillman Cancer Center - Monroeville
        • Principal Investigator:
          • Dan P. Zandberg
        • Contact:
      • Monroeville, Pennsylvania, United States, 15146
        • Recruiting
        • UPMC Cancer Center - Monroeville
        • Contact:
        • Principal Investigator:
          • Dan P. Zandberg
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Thomas Jefferson University Hospital
        • Principal Investigator:
          • Voichita Bar Ad
        • Contact:
      • Philadelphia, Pennsylvania, United States, 19114
        • Recruiting
        • Jefferson Torresdale Hospital
        • Principal Investigator:
          • Voichita Bar Ad
        • Contact:
      • Pittsburgh, Pennsylvania, United States, 15232
        • Recruiting
        • University of Pittsburgh Cancer Institute (UPCI)
        • Contact:
          • Site Public Contact
          • Phone Number: 412-647-8073
        • Principal Investigator:
          • Dan P. Zandberg
      • Pittsburgh, Pennsylvania, United States, 15243
        • Recruiting
        • UPMC-Saint Clair Hospital Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 412-502-3920
        • Principal Investigator:
          • Dan P. Zandberg
      • Pittsburgh, Pennsylvania, United States, 15212
        • Recruiting
        • Allegheny General Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 877-284-2000
        • Principal Investigator:
          • Larisa Greenberg
      • Pittsburgh, Pennsylvania, United States, 15232
        • Recruiting
        • UPMC-Shadyside Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 412-621-2334
        • Principal Investigator:
          • Dan P. Zandberg
      • Pottsville, Pennsylvania, United States, 17901
        • Recruiting
        • Geisinger Cancer Services-Pottsville
        • Contact:
        • Principal Investigator:
          • Fiori Alite
      • Seneca, Pennsylvania, United States, 16346
        • Recruiting
        • UPMC Cancer Center at UPMC Northwest
        • Contact:
          • Site Public Contact
          • Phone Number: 814-676-7900
        • Principal Investigator:
          • Dan P. Zandberg
      • Wexford, Pennsylvania, United States, 15090
        • Recruiting
        • Wexford Health and Wellness Pavilion
        • Contact:
        • Principal Investigator:
          • Larisa Greenberg
      • Wilkes-Barre, Pennsylvania, United States, 18711
        • Recruiting
        • Geisinger Wyoming Valley/Henry Cancer Center
        • Contact:
        • Principal Investigator:
          • Fiori Alite
      • Willow Grove, Pennsylvania, United States, 19090
        • Recruiting
        • Asplundh Cancer Pavilion
        • Principal Investigator:
          • Voichita Bar Ad
        • Contact:
    • South Carolina
      • Greer, South Carolina, United States, 29651
        • Recruiting
        • Gibbs Cancer Center-Pelham
        • Contact:
        • Principal Investigator:
          • Amarinthia (Amy) Curtis
      • Spartanburg, South Carolina, United States, 29303
        • Recruiting
        • Spartanburg Medical Center
        • Contact:
        • Principal Investigator:
          • Amarinthia (Amy) Curtis
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57104
      • Sioux Falls, South Dakota, United States, 57117-5134
    • Utah
      • Farmington, Utah, United States, 84025
        • Recruiting
        • Farmington Health Center
        • Contact:
        • Principal Investigator:
          • Ying J. Hitchcock
      • Salt Lake City, Utah, United States, 84106
        • Recruiting
        • University of Utah Sugarhouse Health Center
        • Contact:
        • Principal Investigator:
          • Ying J. Hitchcock
      • Salt Lake City, Utah, United States, 84112
        • Recruiting
        • Huntsman Cancer Institute/University of Utah
        • Contact:
        • Principal Investigator:
          • Ying J. Hitchcock
      • South Jordan, Utah, United States, 84009
        • Recruiting
        • South Jordan Health Center
        • Contact:
        • Principal Investigator:
          • Ying J. Hitchcock
    • West Virginia
      • Bridgeport, West Virginia, United States, 26330
        • Recruiting
        • United Hospital Center
        • Contact:
        • Principal Investigator:
          • David A. Clump
      • Martinsburg, West Virginia, United States, 25401
        • Recruiting
        • WVUH-Berkely Medical Center
        • Contact:
        • Principal Investigator:
          • David A. Clump
      • Morgantown, West Virginia, United States, 26506
        • Recruiting
        • West Virginia University Healthcare
        • Contact:
        • Principal Investigator:
          • David A. Clump
      • Parkersburg, West Virginia, United States, 26101
        • Recruiting
        • Camden Clark Medical Center
        • Contact:
        • Principal Investigator:
          • David A. Clump
      • Princeton, West Virginia, United States, 24740
        • Recruiting
        • Princeton Community Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 304-487-7515
        • Principal Investigator:
          • David A. Clump
      • Wheeling, West Virginia, United States, 26003
        • Recruiting
        • Wheeling Hospital/Schiffler Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 304-243-6442
        • Principal Investigator:
          • David A. Clump
    • Wisconsin
      • Antigo, Wisconsin, United States, 54409
        • Recruiting
        • Langlade Hospital and Cancer Center
        • Contact:
        • Principal Investigator:
          • Andrew J. Huang
      • Burlington, Wisconsin, United States, 53105
        • Recruiting
        • Aurora Cancer Care-Southern Lakes VLCC
        • Contact:
        • Principal Investigator:
          • Thomas J. Saphner
      • Cudahy, Wisconsin, United States, 53110
        • Recruiting
        • Aurora Saint Luke's South Shore
        • Contact:
        • Principal Investigator:
          • Thomas J. Saphner
      • Germantown, Wisconsin, United States, 53022
        • Recruiting
        • Aurora Health Care Germantown Health Center
        • Contact:
        • Principal Investigator:
          • Thomas J. Saphner
      • Grafton, Wisconsin, United States, 53024
        • Recruiting
        • Aurora Cancer Care-Grafton
        • Contact:
        • Principal Investigator:
          • Thomas J. Saphner
      • Green Bay, Wisconsin, United States, 54311
        • Recruiting
        • Aurora BayCare Medical Center
        • Contact:
        • Principal Investigator:
          • Thomas J. Saphner
      • Kenosha, Wisconsin, United States, 53142
        • Recruiting
        • Aurora Cancer Care-Kenosha South
        • Contact:
        • Principal Investigator:
          • Thomas J. Saphner
      • La Crosse, Wisconsin, United States, 54601
        • Recruiting
        • Gundersen Lutheran Medical Center
        • Contact:
        • Principal Investigator:
          • Michael O. Ojelabi
      • Marinette, Wisconsin, United States, 54143
        • Recruiting
        • Aurora Bay Area Medical Group-Marinette
        • Contact:
        • Principal Investigator:
          • Thomas J. Saphner
      • Medford, Wisconsin, United States, 54451
        • Recruiting
        • Aspirus Medford Hospital
        • Principal Investigator:
          • Andrew J. Huang
        • Contact:
      • Menomonee Falls, Wisconsin, United States, 53051
        • Recruiting
        • Froedtert Menomonee Falls Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 262-257-5100
        • Principal Investigator:
          • Monica E. Shukla
      • Milwaukee, Wisconsin, United States, 53209
        • Recruiting
        • Aurora Cancer Care-Milwaukee
        • Contact:
        • Principal Investigator:
          • Thomas J. Saphner
      • Milwaukee, Wisconsin, United States, 53215
        • Recruiting
        • Aurora Saint Luke's Medical Center
        • Contact:
        • Principal Investigator:
          • Thomas J. Saphner
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Medical College of Wisconsin
        • Contact:
          • Site Public Contact
          • Phone Number: 414-805-3666
        • Principal Investigator:
          • Monica E. Shukla
      • Milwaukee, Wisconsin, United States, 53233
        • Recruiting
        • Aurora Sinai Medical Center
        • Contact:
        • Principal Investigator:
          • Thomas J. Saphner
      • Oak Creek, Wisconsin, United States, 53154
        • Recruiting
        • Drexel Town Square Health Center
        • Contact:
          • Site Public Contact
          • Phone Number: 414-805-0505
        • Principal Investigator:
          • Monica E. Shukla
      • Oshkosh, Wisconsin, United States, 54904
        • Recruiting
        • Vince Lombardi Cancer Clinic - Oshkosh
        • Contact:
        • Principal Investigator:
          • Thomas J. Saphner
      • Racine, Wisconsin, United States, 53406
        • Recruiting
        • Aurora Cancer Care-Racine
        • Contact:
        • Principal Investigator:
          • Thomas J. Saphner
      • Rhinelander, Wisconsin, United States, 54501
        • Recruiting
        • Aspirus Cancer Care - James Beck Cancer Center
        • Principal Investigator:
          • Andrew J. Huang
        • Contact:
      • Sheboygan, Wisconsin, United States, 53081
        • Recruiting
        • Vince Lombardi Cancer Clinic-Sheboygan
        • Contact:
        • Principal Investigator:
          • Thomas J. Saphner
      • Stevens Point, Wisconsin, United States, 54481
        • Recruiting
        • Aspirus Cancer Care - Stevens Point
        • Principal Investigator:
          • Andrew J. Huang
        • Contact:
      • Summit, Wisconsin, United States, 53066
        • Recruiting
        • Aurora Medical Center in Summit
        • Contact:
        • Principal Investigator:
          • Thomas J. Saphner
      • Two Rivers, Wisconsin, United States, 54241
        • Recruiting
        • Vince Lombardi Cancer Clinic-Two Rivers
        • Contact:
        • Principal Investigator:
          • Thomas J. Saphner
      • Wausau, Wisconsin, United States, 54401
        • Recruiting
        • Aspirus Regional Cancer Center
        • Principal Investigator:
          • Andrew J. Huang
        • Contact:
          • Site Public Contact
          • Phone Number: 877-405-6866
      • Wauwatosa, Wisconsin, United States, 53226
        • Recruiting
        • Aurora Cancer Care-Milwaukee West
        • Contact:
        • Principal Investigator:
          • Thomas J. Saphner
      • West Allis, Wisconsin, United States, 53227
        • Recruiting
        • Aurora West Allis Medical Center
        • Contact:
        • Principal Investigator:
          • Thomas J. Saphner
      • West Bend, Wisconsin, United States, 53095
        • Recruiting
        • Froedtert West Bend Hospital/Kraemer Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 414-805-0505
        • Principal Investigator:
          • Monica E. Shukla
      • Wisconsin Rapids, Wisconsin, United States, 54494
        • Recruiting
        • Aspirus Cancer Care - Wisconsin Rapids
        • Principal Investigator:
          • Andrew J. Huang
        • Contact:
          • Site Public Contact
          • Phone Number: 715-422-7718

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Histologic documentation of disease: Squamous cell carcinoma of the head and neck region.

    * Stage: I-IV

  • No prior treatment for head and neck cancer
  • Planned treatment with cisplatin-based chemoradiation therapy (weekly or once every 3 weeks [q 3 week])
  • Able to swallow capsules whole
  • No known hypersensitivity to gabapentin or its ingredients
  • No patients on dialysis or with transplanted organs
  • No prior surgery or radiation for head and neck cancer and/or are being treated for recurrent head and neck cancer. Patients with a history of surgery and radioactive iodine for the treatment of thyroid cancer are eligible. Concurrent cancer therapy for other cancers is not allowed
  • No planned surgery or chemotherapy or immunotherapy following 7 weeks of standard chemoradiation treatment
  • No known brain metastases
  • No nonprescribed use of any opioids (including heroin) within 6 months prior to registration
  • No prescribed medications for chronic and/or long-term pain and/or neuropathy, including patients under treatment of a pain specialist or substance abuse programs. Acute post-biopsy medications are allowed if the patient has discontinued them 3 days prior to study registration
  • No current treatment with mefloquine
  • Age ≥ 18 years
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
  • Creatinine ≤ 1.5 x upper limit of normal (ULN)
  • Not pregnant and not nursing, because this study involves both radiation and chemotherapy. In addition, the genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown. Therefore, for women of childbearing potential, a negative pregnancy test done < 7 days prior to registration is required. Women must agree to using contraception for the duration of receiving study drugs and for 6 months after completing chemoradiation
  • Not taking medications for a psychotic psychiatric illness
  • No existing diagnosis of sleep apnea
  • No acute narrow-angle glaucoma
  • No uncontrolled concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • No investigational agent within 30 days prior to registration
  • No enrollment on other studies of systemic pain control agents
  • Language: In order to complete the mandatory patient-completed measures, participants must be able to speak and read English or Spanish
  • Patients with impaired decision making are not eligible for study

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Arm I (Placebo)
Starting by radiation treatment 8, patients receive placebo PO QD on day 1, BID on day 2, then TID starting day 3 onward. Patients also receive standard of care radiation, chemotherapy and pain medications. Treatment with placebo continues in the absence of disease progression or unacceptable toxicity, until the symptoms of oral mucositis and other treatment effects begin to resolve and other pain medications has been stopped. Patients then continue to receive placebo TID for 9 additional days, at sequentially smaller doses, then BID for 1 day and QD for one day before stopping. Patients undergo blood sample collection throughout the study.
Procedure: Biospecimen Collection
Undergo blood sample collection
Other: Survey Administration
Ancillary studies
Drug: Placebo
Given PO
Drug: Chemotheraphy
Receive standard of care chemotherapy
Radiation: Radiation Therapy
Undergo standard of care radiation
Drug: Analgesic Agent
Receive standard of care pain medication
Experimental: Arm II (Gabapentin)
Starting by radiation treatment 8, patients receive gabapentin PO QD on day 1, BID on day 2, then TID starting day 3 onward. Patients also receive standard of care radiation, chemotherapy and pain medications. Treatment with gabapentin continues in the absence of disease progression or unacceptable toxicity, until the symptoms of oral mucositis and other treatment effects begin to resolve and other pain medications has been stopped. Patients then continue to receive gabapentin TID for 9 additional days, at sequentially smaller doses, then BID for 1 day and QD for one day before stopping. Patients undergo blood sample collection throughout the study.
Procedure: Biospecimen Collection
Undergo blood sample collection
Other: Survey Administration
Ancillary studies
Drug: Gabapentin
Given PO
Other Names:
  • Gralise
  • Neurontin
Drug: Chemotheraphy
Receive standard of care chemotherapy
Radiation: Radiation Therapy
Undergo standard of care radiation
Drug: Analgesic Agent
Receive standard of care pain medication

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Need to use opioids during chemoradiation therapy (CRT)
Time Frame: Up to 7 weeks
Will be tested using a two-sample test of proportions. Will report the proportion of patients not using opioids within the 7 weeks of CRT in the two arms and the 95% confidence interval (CI) of the difference in the proportions.
Up to 7 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to first opioid use
Time Frame: Up to 9 weeks
Time to first opioid use, defined as the time from randomization to the first occurrence of opioid use during CRT, censoring patients alive and opioid free at CRT completion. Death or disease progression before first opioid use during CRT will be treated as competing events. Cumulative incidence functions will be used to estimate the percentage of patients who experience the competing events within the arms. Differences between the cumulative incidence functions between the arms will be tested for statistical significance using the procedure of Gray. The cumulative incidence percentage at the end of CRT by arm will be reported.
Up to 9 weeks
Patient-reported pain scores
Time Frame: Through 4 weeks post CRT (up to 14 weeks)
Pain score responses of question #5 on the Oral Mucositis Weekly Questionnaire-Head and Neck Cancer (OMWQ-HN) survey at each collected timepoint for each arm. This NRS item asks a respondent to rate their overall mouth and throat soreness during the past week from 0 (no soreness) to 10 (worst possible soreness). Will apply longitudinal modeling of the patient-reported pain scores through four weeks post CRT treatment. Will report each time-specific comparison between arms with a 95% CI.
Through 4 weeks post CRT (up to 14 weeks)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Need to use opioids during CRT by sex
Time Frame: Up to 7 weeks
Will be assessed between arms and the corresponding 95% CIs will be provided by sex (male; female).
Up to 7 weeks
Need to use opioids during CRT by race
Time Frame: Up to 7 weeks
Will be assessed between arms and the corresponding 95% CIs will be provided by race (white; other).
Up to 7 weeks
Need to use opioids during CRT by ethnicity
Time Frame: Up to 7 weeks
Will be assessed between arms and the corresponding 95% CIs will be provided by ethnicity (Not Hispanic or Latino; Hispanic or Latino).
Up to 7 weeks
Duration of opioid use
Time Frame: Though 4 weeks post CRT (up to 14 weeks)
Will report the number of patients and descriptively summarize the duration of opioid use from the time of initiation to cessation, or 4 weeks post-CRT (acute opioid use), whichever comes first. Descriptive statistics will include the mean, standard deviation, median, interquartile range, minimum, and maximum.
Though 4 weeks post CRT (up to 14 weeks)
Global health
Time Frame: Through 4 weeks post CRT (up to 14 weeks)
Measured via OMWQ-HN. The first two items of the OMWQ-HN assess global health and quality of life and are rated on a seven-point scale, with one indicating very poor and seven indicating excellent. The focus will be on the interaction effect, which concerns comparisons of the patterns of changes in the mean patient-reported pain scores. In addition to plotting the model-based mean response profiles by arm, will report each time specific comparison between arms with a 95% CI.
Through 4 weeks post CRT (up to 14 weeks)
Patient reported oral mucositis symptoms.
Time Frame: Through 4 weeks post CRT (up to 14 weeks)
Measured via OMWQ-HN. The third item of the OMWQ-HN assesses mouth and throat soreness and is rated on a five-point scale, with zero indicating no soreness and four indicating extreme soreness. The focus will be on the interaction effect, which concerns comparisons of the patterns of changes in the mean patient-reported pain scores. In addition to plotting the model-based mean response profiles by arm, will report each time specific comparison between arms with a 95% CI.
Through 4 weeks post CRT (up to 14 weeks)
Mouth and throat soreness
Time Frame: Through 4 weeks post CRT (up to 14 weeks)
Measured via OMWQ-HN. The last three items of the OMWQ-HN assess the degree of mouth and throat pain and soreness using an 11-point scale, with zero indicating no pain or soreness and 10 indicating the worst pain or soreness imaginable or possible. The focus will be on the interaction effect, which concerns comparisons of the patterns of changes in the mean patient-reported pain scores. In addition to plotting the model-based mean response profiles by arm, will report each time specific comparison between arms with a 95% CI.
Through 4 weeks post CRT (up to 14 weeks)
Impact of mouth and throat soreness on patient function
Time Frame: Through 4 weeks post CRT (up to 14 weeks)
Measured via OMWQ-HN. The fourth item of the OMWQ-HN, which is made up six different activities each rated on a five-point scale (0 = not limited and 4 = unable to do), assesses the impact of mouth and throat soreness on patient function; responses to the six different activities are summed (range: 0 to 24), with lower scores being better. The focus will be on the interaction effect, which concerns comparisons of the patterns of changes in the mean patient-reported pain scores. In addition to plotting the model-based mean response profiles by arm, will report each time specific comparison between arms with a 95% CI.
Through 4 weeks post CRT (up to 14 weeks)
Incidence of symptoms or problems
Time Frame: Through 4 weeks post CRT (up to 14 weeks)
Measured on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck-43. The scales and singles arms range from 0-100, with higher scores indicating fewer symptoms or problems; a change of 10 units on the 0-100 response scale is regarded as considered clinically important. The focus will be on the interaction effect, which concerns comparisons of the patterns of changes in the mean patient-reported pain scores. In addition to plotting the model-based mean response profiles by arm, will report each time specific comparison between arms with a 95% CI.
Through 4 weeks post CRT (up to 14 weeks)
Incidence of adverse events (AE)
Time Frame: Up to approximately 2 years
As scored using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v 5.0). Will be summarized within arms by reporting the number and percentages of patients. Specifically, to evaluate the AE profiles within each arm, the maximum grade for each type of AE will be recorded for each patient and frequency tables will be reviewed to determine overall patterns; additionally, the proportion of somnolence, confusion, and gait disturbance using NCI CTCAE v 5.0 will be estimated within arms with the exact 90% CI.
Up to approximately 2 years
Tolerance of gabapentin
Time Frame: Up to the 9 weeks
Defined as ≥ 80% adherence (yes; no) to gabapentin during CRT. The proportion of patients that complete CRT and tolerate gabapentin during CRT will be reported.
Up to the 9 weeks
Body mass index
Time Frame: Up to the 9 weeks
Descriptive statistics will include the mean, standard deviation, median, interquartile range, minimum, and maximum.
Up to the 9 weeks
Creatinine
Time Frame: Up to the 9 weeks
Descriptive statistics will include the mean, standard deviation, median, interquartile range, minimum, and maximum.
Up to the 9 weeks
Absolute neutrophil count
Time Frame: From baseline to the completion of CRT
Descriptive statistics will include the mean, standard deviation, median, interquartile range, minimum, and maximum.
From baseline to the completion of CRT
Dose of prescribed opioids
Time Frame: Up to 7 weeks.
The patient average dose of prescribed opioids will be standardized using the Morphine Milligram Equivalent calculator. Will summarize the within patient average dose of prescribed opioids according to arm using the mean, standard deviation, median, interquartile range, minimum, and maximum values.
Up to 7 weeks.
Incidence of Feeding Tube
Time Frame: Through 4 weeks post CRT (up to 14 weeks)
Will report the frequency and percentage of patients within each arm who require a feeding tube during CRT.
Through 4 weeks post CRT (up to 14 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alliance for Clinical Trials in Oncology

Collaborators

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 5, 2025

Primary Completion (Estimated)

August 15, 2029

Study Completion (Estimated)

April 15, 2031

Study Registration Dates

First Submitted

April 28, 2025

First Submitted That Met QC Criteria

May 19, 2025

First Posted (Actual)

May 28, 2025

Study Record Updates

Last Update Posted (Actual)

May 11, 2026

Last Update Submitted That Met QC Criteria

May 7, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A222301
  • NCI-2025-00501 (Registry Identifier: NCI Clinical Trial Reporting Program)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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