Doxepin and a Topical Rinse in the Treatment of Acute Oral Mucositis Pain in Patients Receiving Radiotherapy With or Without Chemotherapy

October 4, 2019 updated by: Alliance for Clinical Trials in Oncology

A Phase III Placebo-Controlled, Randomized Three-Arm Study of Doxepin and a Topical Rinse in the Treatment of Acute Oral Mucositis Pain in Patients Receiving Radiotherapy With or Without Chemotherapy

The purpose of this study is to test whether a mouthwash made with a drug called doxepin can reduce the pain caused by mouth sores resulting from radiation therapy. A number of mouth rinse preparations exist for patients with treatment-related oral mucositis pain such as the DLA rinse, an over-the-counter medication. This study will evaluate the effects of doxepin compared to DLA (diphenhydramine, lidocaine and antacids) and placebo.Doxepin is approved by the Food and Drug Administration (FDA) for the treatment of depression, anxiety, long-term pain management, as well as management of rash.

Study Overview

Detailed Description

Patients are stratified according to sex (male vs. female), concurrent use of chemotherapy (no vs. yes), patient age at registration (< 60 years old vs. ≥ 60 years old and RTOG acute radiation morbidity criteria (1 vs. 2 vs 3 or more). Protocol therapy will consist of 2 cycles. Patients are randomized to one of three treatment regimens, which include doxepin, DLA and placebo. Cycle One will consist of one day. The care provider or nurse will confirm that the oral pain is at least 4 out of 10 severity level at the time of the rinse on the first day of the study. Patient will be asked to complete the baseline evaluation in the Oral Symptoms booklet. If the pain score is less than 4 then administration will be delayed until the pain is at least 4. Cycle Two will consist of an optional continuation phase lasting up to 7 days. Initiation of the Cycle 2/Continuation Phase may be delayed up to one week after Cycle 1/Day 1.

Primary Objective:

1. Determine whether the doxepin rinse or DLA rinse is more effective than placebo in reducing OM-related pain in patients undergoing RT to the oral cavity, as measured by a patient-reported questionnaire at baseline, 5 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, and 4 hours.

Secondary Objectives:

  1. Assess the adverse event profile of the doxepin rinse, the DLA rinse agent, and the placebo using a patient-reported questionnaire at 5 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, and 4 hours for domains of unpleasant taste, burning or stinging discomfort, and drowsiness.
  2. Compare the incidence of using additional analgesics between 1 and 4 hours after the initial mouthwash, between the doxepin oral rinse, the DLA rinse agent, and the placebo arms.
  3. Compare the length of time that each study product is used by patients in the one-week continuation phase.
  4. Compare the daily pain scores in the one-week continuation phase for the three study arms.
  5. Compare the 24-hour morphine equivalent dose used in the continuation phase for the three study arms.

Study Type

Interventional

Enrollment (Actual)

275

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 Locations

    • Alaska
      • Anchorage, Alaska, United States, 99508
        • Alaska Breast Care and Surgery LLC
      • Anchorage, Alaska, United States, 99508
        • Alaska Oncology and Hematology LLC
      • Anchorage, Alaska, United States, 99508
        • Alaska Women's Cancer Care
      • Anchorage, Alaska, United States, 99508
        • Anchorage Oncology Centre
      • Anchorage, Alaska, United States, 99508
        • Katmai Oncology Group
      • Anchorage, Alaska, United States, 99508
        • Providence Alaska Medical Center
      • Anchorage, Alaska, United States, 99504
        • Anchorage Radiation Therapy Center
      • Anchorage, Alaska, United States, 99508
        • Alaska Regional Hospital
    • California
      • Burbank, California, United States, 91505
        • Providence Saint Joseph Medical Center/Disney Family Cancer Center
      • Dublin, California, United States, 94568
        • Epic Care-Dublin
      • Emeryville, California, United States, 94608
        • Bay Area Breast Surgeons Inc
      • Emeryville, California, United States, 94608
        • Epic Care Partners in Cancer Care
      • Englewood, California, United States, 80113
        • Comprehensive Cancer Care and Research Institute of Colorado LLC
      • Martinez, California, United States, 94553-3156
        • Contra Costa Regional Medical Center
      • Oakland, California, United States, 94609
        • Alta Bates Summit Medical Center - Summit Campus
      • Oakland, California, United States, 94609
        • Bay Area Tumor Institute CCOP
      • Oakland, California, United States, 94609
        • Hematology and Oncology Associates-Oakland
    • Colorado
      • Aurora, Colorado, United States, 80012
        • Rocky Mountain Cancer Centers-Aurora
      • Aurora, Colorado, United States, 80012
        • The Medical Center of Aurora
      • Boulder, Colorado, United States, 80301
        • Boulder Community Hospital
      • Boulder, Colorado, United States, 80304
        • Rocky Mountain Cancer Centers-Boulder
      • Colorado Springs, Colorado, United States, 80907
        • Penrose-Saint Francis Healthcare
      • Colorado Springs, Colorado, United States, 80907
        • Rocky Mountain Cancer Centers-Penrose
      • Denver, Colorado, United States, 80210
        • Porter Adventist Hospital
      • Denver, Colorado, United States, 80218
        • Presbyterian - Saint Lukes Medical Center - Health One
      • Denver, Colorado, United States, 80220
        • Rose Medical Center
      • Denver, Colorado, United States, 80218
        • Exempla Saint Joseph Hospital
      • Denver, Colorado, United States, 80218
        • Rocky Mountain Cancer Centers-Midtown
      • Denver, Colorado, United States, 80220
        • Rocky Mountain Cancer Centers-Rose
      • Denver, Colorado, United States, 80907
        • Colorado Blood Cancer Institute
      • Durango, Colorado, United States, 81301
        • Mercy Medical Center
      • Durango, Colorado, United States, 81301
        • Southwest Oncology PC
      • Englewood, Colorado, United States, 80110
        • Swedish Medical Center
      • Golden, Colorado, United States, 80401
        • Mountain Blue Cancer Care Center
      • Greeley, Colorado, United States, 80631
        • North Colorado Medical Center
      • Greenwood Village, Colorado, United States, 80111
        • Rocky Mountain Cancer Centers-Greenwood Village
      • Lakewood, Colorado, United States, 80228
        • Saint Anthony Hospital
      • Lakewood, Colorado, United States, 80228
        • Rocky Mountain Cancer Centers-Lakewood
      • Littleton, Colorado, United States, 80120
        • Rocky Mountain Cancer Centers-Littleton
      • Littleton, Colorado, United States, 80122
        • Littleton Adventist Hospital
      • Lone Tree, Colorado, United States, 80124
        • Sky Ridge Medical Center
      • Lone Tree, Colorado, United States, 80124
        • Rocky Mountain Cancer Centers-Sky Ridge
      • Longmont, Colorado, United States, 80501
        • Longmont United Hospital
      • Longmont, Colorado, United States, 80501
        • Rocky Mountain Cancer Centers-Longmont
      • Loveland, Colorado, United States, 80539
        • McKee Medical Center
      • Parker, Colorado, United States, 80138
        • Parker Adventist Hospital
      • Parker, Colorado, United States, 80138
        • Rocky Mountain Cancer Centers-Parker
      • Pueblo, Colorado, United States, 81004
        • Saint Mary Corwin Medical Center
      • Pueblo, Colorado, United States, 81008
        • Rocky Mountain Cancer Centers - Pueblo
      • Thornton, Colorado, United States, 80260
        • Rocky Mountain Cancer Centers-Thornton
      • Wheat Ridge, Colorado, United States, 80033
        • Exempla Lutheran Medical Center
    • Connecticut
      • Hartford, Connecticut, United States, 06105
        • Saint Francis Hospital and Medical Center
      • Middletown, Connecticut, United States, 06457
        • Middlesex Hospital
    • District of Columbia
      • Washington, District of Columbia, United States, 20422
        • Veterans Affairs Medical Center - Washington, DC
    • Florida
      • Clearwater, Florida, United States, 33756
        • Morton Plant Hospital
      • Hollywood, Florida, United States, 33021
        • Memorial Regional Hospital/Joe DiMaggio Children's Hospital
      • Miami Beach, Florida, United States, 33140
        • Mount Sinai Medical Center
      • Pembroke Pines, Florida, United States, 33028
        • Memorial Hospital West
      • Tampa, Florida, United States, 33607
        • Saint Joseph's Hospital/Children's Hospital-Tampa
    • Idaho
      • Boise, Idaho, United States, 83706
        • Saint Alphonsus Cancer Care Center-Boise
      • Boise, Idaho, United States, 83712
        • Saint Luke's Mountain States Tumor Institute
      • Fruitland, Idaho, United States, 83619
        • Saint Luke's Mountain States Tumor Institute - Fruitland
      • Meridian, Idaho, United States, 83642
        • Saint Luke's Mountain States Tumor Institute - Meridian
      • Nampa, Idaho, United States, 83686
        • Saint Luke's Mountain States Tumor Institute - Nampa
      • Twin Falls, Idaho, United States, 83301
        • Saint Luke's Mountain States Tumor Institute-Twin Falls
    • Illinois
      • Bloomington, Illinois, United States, 61701
        • Saint Joseph Medical Center
      • Bloomington, Illinois, United States, 61701
        • Illinois CancerCare - Bloomington
      • Canton, Illinois, United States, 61520
        • Illinois CancerCare - Canton
      • Carbondale, Illinois, United States, 62902
        • Memorial Hospital of Carbondale
      • Centralia, Illinois, United States, 62801
        • Centralia Oncology Clinic
      • Decatur, Illinois, United States, 62526
        • Decatur Memorial Hospital
      • Decatur, Illinois, United States, 62526
        • Heartland Cancer Research NCORP
      • Decatur, Illinois, United States, 62526
        • Cancer Care Specialists of Central Illinois
      • Effingham, Illinois, United States, 62401
        • Crossroads Cancer Center
      • Eureka, Illinois, United States, 61530
        • Illinois CancerCare - Eureka
      • Galesburg, Illinois, United States, 61401
        • Western Illinois Cancer Treatment Center
      • Galesburg, Illinois, United States, 61401
        • Illinois CancerCare - Galesburg
      • Kewanee, Illinois, United States, 61443
        • Illinois CancerCare - Kewanee Clinic
      • Macomb, Illinois, United States, 61455
        • Illinois CancerCare - Macomb
      • Moline, Illinois, United States, 61265
        • Garneau, Stewart C MD (UIA Investigator)
      • Moline, Illinois, United States, 61265
        • Spector, David MD (UIA Investigator)
      • Moline, Illinois, United States, 61265
        • Trinity Medical Center
      • Ottawa, Illinois, United States, 61350
        • Radiation Oncology of Northern Illinois
      • Ottawa, Illinois, United States, 61350
        • Illinois CancerCare- Ottawa Clinic
      • Pekin, Illinois, United States, 61554
        • Illinois CancerCare-Pekin
      • Pekin, Illinois, United States, 61554
        • Pekin Cancer Treatment Center
      • Peoria, Illinois, United States, 61615
        • Illinois CancerCare-Peoria
      • Peoria, Illinois, United States, 61603
        • Methodist Medical Center of Illinois
      • Peoria, Illinois, United States, 61615-7827
        • OSF Saint Francis Medical Center Radiation Oncology Service at the Central Illinois Comprehensive CC
      • Peoria, Illinois, United States, 61637
        • OSF St. Francis Medical Center
      • Peru, Illinois, United States, 61354
        • Illinois CancerCare-Peru
      • Peru, Illinois, United States, 61354
        • Valley Radiation Oncology
      • Princeton, Illinois, United States, 61356
        • Illinois CancerCare-Princeton
      • Rockford, Illinois, United States, 61108
        • OSF Saint Anthony Medical Center
      • Springfield, Illinois, United States, 62702
        • Central Illinois Hematology Oncology Center
      • Springfield, Illinois, United States, 62703
        • Springfield Clinic
      • Springfield, Illinois, United States, 62781-0001
        • Memorial Medical Center
      • Swansea, Illinois, United States, 62226
        • Cancer Care Specialists of Illinois-Swansea
    • Indiana
      • Mishawaka, Indiana, United States, 46544
        • Memorial Regional Cancer Center Day Road
      • South Bend, Indiana, United States, 46601
        • Memorial Hospital of South Bend
    • Iowa
      • Bettendorf, Iowa, United States, 52722
        • Constantinou, Costas L MD (UIA Investigator)
      • Cedar Rapids, Iowa, United States, 52403
        • Mercy Hospital
      • Cedar Rapids, Iowa, United States, 52403
        • Oncology Associates at Mercy Medical Center
      • Des Moines, Iowa, United States, 50309
        • Iowa Methodist Medical Center
      • Des Moines, Iowa, United States, 50316
        • Iowa Lutheran Hospital
      • Des Moines, Iowa, United States, 50309
        • Medical Oncology and Hematology Associates - Des Moines
      • Sioux City, Iowa, United States, 51101
        • Siouxland Regional Cancer Center
      • West Des Moines, Iowa, United States, 50266
        • Methodist West Hospital
    • Kansas
      • Chanute, Kansas, United States, 66720
        • Cancer Center of Kansas - Chanute
      • Dodge City, Kansas, United States, 67801
        • Cancer Center of Kansas - Dodge City
      • El Dorado, Kansas, United States, 67042
        • Cancer Center of Kansas - El Dorado
      • Fort Scott, Kansas, United States, 66701
        • Cancer Center of Kansas - Fort Scott
      • Independence, Kansas, United States, 67301
        • Cancer Center of Kansas - Independence
      • Kingman, Kansas, United States, 67068
        • Cancer Center of Kansas - Kingman
      • Lawrence, Kansas, United States, 66044
        • Lawrence Memorial Hospital
      • Liberal, Kansas, United States, 67901
        • Cancer Center of Kansas - Liberal
      • Newton, Kansas, United States, 67114
        • Cancer Center of Kansas - Newton
      • Parsons, Kansas, United States, 67357
        • Cancer Center of Kansas - Parsons
      • Pratt, Kansas, United States, 67124
        • Cancer Center of Kansas - Pratt
      • Salina, Kansas, United States, 67401
        • Cancer Center of Kansas - Salina
      • Wellington, Kansas, United States, 67152
        • Cancer Center of Kansas - Wellington
      • Wichita, Kansas, United States, 67208
        • Associates In Womens Health
      • Wichita, Kansas, United States, 67208
        • Cancer Center of Kansas - Wichita Medical Arts Tower
      • Wichita, Kansas, United States, 67214
        • Cancer Center of Kansas - Main Office
      • Wichita, Kansas, United States, 67214
        • Via Christi Regional Medical Center
      • Wichita, Kansas, United States, 67214
        • Wesley Medical Center
      • Winfield, Kansas, United States, 67156
        • Cancer Center of Kansas - Winfield
    • Maine
      • Portland, Maine, United States, 04102
        • Maine Medical Center - Bramhall Campus
    • Michigan
      • Ann Arbor, Michigan, United States, 48106
        • Saint Joseph Mercy Hospital
      • Battle Creek, Michigan, United States, 49017
        • Bronson Battle Creek
      • Dearborn, Michigan, United States, 48124
        • Oakwood Hospital and Medical Center
      • Detroit, Michigan, United States, 48236
        • Saint John Hospital and Medical Center
      • Escanaba, Michigan, United States, 49431
        • Green Bay Oncology - Escanaba
      • Flint, Michigan, United States, 48503
        • Hurley Medical Center
      • Flint, Michigan, United States, 48503
        • Genesys Hurley Cancer Institute
      • Grand Rapids, Michigan, United States, 49503
        • Spectrum Health at Butterworth Campus
      • Grand Rapids, Michigan, United States, 49503
        • Mercy Health Saint Mary's
      • Iron Mountain, Michigan, United States, 49801
        • Green Bay Oncology - Iron Mountain
      • Jackson, Michigan, United States, 49201
        • Allegiance Health
      • Kalamazoo, Michigan, United States, 49007
        • Bronson Methodist Hospital
      • Kalamazoo, Michigan, United States, 49001
        • Borgess Medical Center
      • Kalamazoo, Michigan, United States, 49007-3731
        • West Michigan Cancer Center
      • Lansing, Michigan, United States, 48912
        • Sparrow Hospital
      • Livonia, Michigan, United States, 48154
        • Saint Mary Mercy Hospital
      • Muskegon, Michigan, United States, 49444
        • Mercy Health Mercy Campus
      • Niles, Michigan, United States, 49120
        • Lakeland Community Hospital
      • Pontiac, Michigan, United States, 48341
        • Saint Joseph Mercy Oakland
      • Port Huron, Michigan, United States, 48060
        • Saint Joseph Mercy Port Huron
      • Reed City, Michigan, United States, 49677
        • Spectrum Health Reed City Hospital
      • Royal Oak, Michigan, United States, 48073
        • William Beaumont Hospital - Royal Oak
      • Saginaw, Michigan, United States, 48601
        • Saint Mary's of Michigan
      • Saint Joseph, Michigan, United States, 49085
        • Marie Yeager Cancer Center
      • Saint Joseph, Michigan, United States, 49085
        • Lakeland Hospital
      • Traverse City, Michigan, United States, 49684
        • Munson Medical Center
      • Troy, Michigan, United States, 48098
        • William Beaumont Hospital - Troy
      • Warren, Michigan, United States, 48093
        • Saint John Macomb-Oakland Hospital
    • Minnesota
      • Bemidji, Minnesota, United States, 56601
        • Sanford Clinic North-Bemidji
      • Burnsville, Minnesota, United States, 55337
        • Fairview Ridges Hospital
      • Coon Rapids, Minnesota, United States, 55433
        • Mercy Hospital
      • Edina, Minnesota, United States, 55435
        • Fairview Southdale Hospital
      • Fridley, Minnesota, United States, 55432
        • Unity Hospital
      • Hutchinson, Minnesota, United States, 55350
        • Hutchinson Area Health Care
      • Maplewood, Minnesota, United States, 55109
        • Saint John's Hospital - Healtheast
      • Maplewood, Minnesota, United States, 55109
        • Minnesota Oncology Hematology PA-Maplewood
      • Minneapolis, Minnesota, United States, 55415
        • Hennepin County Medical Center
      • Minneapolis, Minnesota, United States, 55407
        • Abbott-Northwestern Hospital
      • Minneapolis, Minnesota, United States, 55454
        • Health Partners Inc
      • New Ulm, Minnesota, United States, 56073
        • New Ulm Medical Center
      • Robbinsdale, Minnesota, United States, 55422
        • North Memorial Medical Health Center
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
      • Saint Louis Park, Minnesota, United States, 55416
        • Park Nicollet Clinic - Saint Louis Park
      • Saint Paul, Minnesota, United States, 55101
        • Regions Hospital
      • Saint Paul, Minnesota, United States, 55102
        • United Hospital
      • Shakopee, Minnesota, United States, 55379
        • Saint Francis Regional Medical Center
      • Stillwater, Minnesota, United States, 55082
        • Lakeview Hospital
      • Waconia, Minnesota, United States, 55387
        • Ridgeview Medical Center
      • Willmar, Minnesota, United States, 56201
        • Rice Memorial Hospital
      • Woodbury, Minnesota, United States, 55125
        • Minnesota Oncology Hematology PA-Woodbury
    • Missouri
      • Bolivar, Missouri, United States, 65613
        • Central Care Center - Carrie J. Babb Cancer Center
      • Bonne Terre, Missouri, United States, 63628
        • Parkland Health Center-Bonne Terre
      • Branson, Missouri, United States, 65616
        • Cox Cancer Center Branson
      • Cape Girardeau, Missouri, United States, 63703
        • Saint Francis Medical Center
      • Cape Girardeau, Missouri, United States, 63703
        • Southeast Cancer Center
      • Jefferson City, Missouri, United States, 65109
        • Capital Region Medical Center-Goldschmidt Cancer Center
      • Rolla, Missouri, United States, 65401
        • Mercy Clinic-Rolla-Cancer and Hematology
      • Rolla, Missouri, United States, 65401
        • Phelps County Regional Medical Center
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
      • Saint Louis, Missouri, United States, 63131
        • Missouri Baptist Medical Center
      • Saint Louis, Missouri, United States, 63141
        • Mercy Hospital Saint Louis
      • Saint Louis, Missouri, United States, 63129
        • Siteman Cancer Center-South County
      • Saint Louis, Missouri, United States, 63109
        • Saint Louis Cancer and Breast Institute - South City
      • Saint Louis, Missouri, United States, 63141
        • Barnes-Jewish West County Hospital
      • Sainte Genevieve, Missouri, United States, 63670
        • Sainte Genevieve County Memorial Hospital
      • Springfield, Missouri, United States, 65804
        • Cancer Research for the Ozarks NCORP
      • Springfield, Missouri, United States, 65804
        • Mercy Hospital Springfield
      • Springfield, Missouri, United States, 65807
        • Cox Health South Hospital
      • Sullivan, Missouri, United States, 63080
        • Missouri Baptist Sullivan Hospital
      • Sunset Hills, Missouri, United States, 63127
        • Missouri Baptist Outpatient Center-Sunset Hills
    • Nevada
      • Henderson, Nevada, United States, 89052
        • Comprehensive Cancer Centers of Nevada - Henderson
      • Henderson, Nevada, United States, 89052
        • Las Vegas Cancer Center-Henderson
      • Henderson, Nevada, United States, 89074
        • Comprehensive Cancer Centers of Nevada-Southeast Henderson
      • Henderson, Nevada, United States, 89074
        • 21st Century Oncology-Henderson
      • Las Vegas, Nevada, United States, 89106
        • Radiation Oncology Centers of Nevada Central
      • Las Vegas, Nevada, United States, 89119
        • Radiation Oncology Centers of Nevada Southeast
      • Las Vegas, Nevada, United States, 89128
        • Comprehensive Cancer Centers of Nevada - Northwest
      • Las Vegas, Nevada, United States, 89144
        • Comprehensive Cancer Centers of Nevada-Summerlin
      • Las Vegas, Nevada, United States, 89169
        • Comprehensive Cancer Centers of Nevada - Central Valley
      • Las Vegas, Nevada, United States, 89102
        • University Medical Center of Southern Nevada
      • Las Vegas, Nevada, United States, 89109
        • HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
      • Las Vegas, Nevada, United States, 89113
        • HealthCare Partners Medical Group Oncology/Hematology-San Martin
      • Las Vegas, Nevada, United States, 89121
        • Cancer Therapy and Integrative Medicine
      • Las Vegas, Nevada, United States, 89128
        • Cancer and Blood Specialists-Tenaya
      • Las Vegas, Nevada, United States, 89128
        • HealthCare Partners Medical Group Oncology/Hematology-Tenaya
      • Las Vegas, Nevada, United States, 89148-2405
        • Las Vegas Cancer Center-Medical Center
      • Las Vegas, Nevada, United States, 89149
        • HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
      • Las Vegas, Nevada, United States, 89169
        • Comprehensive Cancer Centers of Nevada
      • Las Vegas, Nevada, United States, 89106
        • Cancer and Blood Specialists-Henderson
      • Las Vegas, Nevada, United States, 89106
        • Nevada Cancer Research Foundation NCORP
      • Las Vegas, Nevada, United States, 89109
        • 21st Century Oncology
      • Las Vegas, Nevada, United States, 89128
        • 21st Century Oncology-Vegas Tenaya
      • Las Vegas, Nevada, United States, 89128
        • Cancer and Blood Specialists-Shadow
      • Las Vegas, Nevada, United States, 89148
        • 21st Century Oncology-Fort Apache
      • Las Vegas, Nevada, United States, 89148
        • Cancer and Blood Specialists-Fort Apache
    • New York
      • Buffalo, New York, United States, 14263
        • Roswell Park Cancer Institute
      • Buffalo, New York, United States, 14215
        • Veterans Affairs Western New York Health Care System-Buffalo
      • New Hyde Park, New York, United States, 11040
        • North Shore-LIJ Health System/Center for Advanced Medicine
    • North Carolina
      • Asheboro, North Carolina, United States, 27203
        • Randolph Hospital
      • Charlotte, North Carolina, United States, 28204
        • Novant Health Presbyterian Medical Center
      • Charlotte, North Carolina, United States, 28207
        • Oncology Specialists of Charlotte
      • Charlotte, North Carolina, United States, 28207
        • Carolina Surgical Clinic of Charlotte PA
      • Charlotte, North Carolina, United States, 28262
        • Southern Oncology Specialists-Charlotte
      • Clinton, North Carolina, United States, 28328
        • Southeastern Medical Oncology Center-Clinton
      • Gastonia, North Carolina, United States, 28054
        • CaroMont Regional Medical Center
      • Goldsboro, North Carolina, United States, 27534
        • Southeastern Medical Oncology Center-Goldsboro
      • Goldsboro, North Carolina, United States, 27534
        • Wayne Memorial Hospital
      • Greensboro, North Carolina, United States, 27403
        • Cone Health Cancer Center
      • Hendersonville, North Carolina, United States, 28791
        • Margaret R Pardee Memorial Hospital
      • Hendersonville, North Carolina, United States, 28739
        • Hendersonville Hematology and Oncology at Pardee
      • Huntersville, North Carolina, United States, 28078
        • Southern Oncology Specialists-Huntersville
      • Huntersville, North Carolina, United States, 28078
        • Lake Norman Hematology Oncology Specialists-Huntersville
      • Huntersville, North Carolina, United States, 287078
        • Lake Norman Hematology Oncology Specialists-Huntersville
      • Jacksonville, North Carolina, United States, 28546
        • Southeastern Medical Oncology Center-Jacksonville
      • Kernersville, North Carolina, United States, 27284
        • Novant Health Oncology Specialists-Kernersville
      • Lexington, North Carolina, United States, 27295
        • Novant Health Oncology Specialists-Davidson County
      • Matthews, North Carolina, United States, 28105
        • Novant Health Cancer Specialists-Matthews
      • Matthews, North Carolina, United States, 28105
        • Matthews Radiation Oncology Center
      • Mooresville, North Carolina, United States, 28117
        • Lake Norman Hematology Oncology Specialists-Mooresville
      • Mount Airy, North Carolina, United States, 27030
        • Novant Health Oncology Specialists-Mount Airy
      • Pinehurst, North Carolina, United States, 28374
        • FirstHealth of the Carolinas-Moore Regional Hospital
      • Reidsville, North Carolina, United States, 27320
        • Annie Penn Memorial Hospital
      • Salisbury, North Carolina, United States, 28144
        • Carolina Oncology Associates PA
      • Statesville, North Carolina, United States, 28625
        • Novant Health Oncology Specialists-Statesville
      • Wilkesboro, North Carolina, United States, 28659
        • Novant Health Oncology Specialists-Wilkesboro
      • Wilson, North Carolina, United States, 27893
        • Southeastern Medical Oncology Center-Wilson
      • Winston-Salem, North Carolina, United States, 27103
        • Novant Health Forsyth Medical Center
      • Winston-Salem, North Carolina, United States, 27103
        • Novant Health Oncology Specialists
      • Winston-Salem, North Carolina, United States, 27103
        • Winston-Salem Health Care
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
        • Sanford Bismarck Medical Center
      • Fargo, North Dakota, United States, 58122
        • Sanford Roger Maris Cancer Center
      • Fargo, North Dakota, United States, 58102
        • Sanford Clinic North-Fargo
      • Fargo, North Dakota, United States, 58122
        • Sanford Medical Center-Fargo
      • Grand Forks, North Dakota, United States, 58201
        • Altru Cancer Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Mercy Hospital Oklahoma City
    • Oregon
      • Bend, Oregon, United States, 97701
        • Saint Charles Health System
      • Clackamas, Oregon, United States, 97015
        • Clackamas Radiation Oncology Center
      • Clackamas, Oregon, United States, 97015
        • Providence Oncology and Hematology Care Southeast
      • Coos Bay, Oregon, United States, 97420
        • Bay Area Hospital
      • Newberg, Oregon, United States, 97132
        • Providence Newberg Medical Center
      • Oregon City, Oregon, United States, 97045
        • Providence Willamette Falls Medical Center
      • Portland, Oregon, United States, 97213
        • Providence Portland Medical Center
      • Portland, Oregon, United States, 97225
        • Providence Saint Vincent Medical Center
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822
        • Geisinger Medical Center
      • Gettysburg, Pennsylvania, United States, 17325
        • Adams Cancer Center
      • Hazleton, Pennsylvania, United States, 18201
        • Geisinger Medical Center-Cancer Center Hazelton
      • Lewistown, Pennsylvania, United States, 17044
        • Lewistown Hospital
      • Pottsville, Pennsylvania, United States, 17901
        • Geisinger Medical Oncology-Pottsville
      • State College, Pennsylvania, United States, 16801
        • Geisinger Medical Group
      • Wilkes-Barre, Pennsylvania, United States, 18711
        • Geisinger Wyoming Valley/Henry Cancer Center
      • York, Pennsylvania, United States, 17405
        • WellSpan Health-York Hospital
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • AnMed Health Cancer Center
      • Beaufort, South Carolina, United States, 29902
        • Beaufort Memorial Hospital
      • Easley, South Carolina, United States, 29640
        • Greenville Health System Cancer Institute-Easley
      • Gaffney, South Carolina, United States, 29341
        • Gibbs Cancer Center-Gaffney
      • Greenville, South Carolina, United States, 29605
        • Greenville Health System Cancer Institute - Butternut
      • Greenville, South Carolina, United States, 29605
        • Greenville Health System Cancer Institute-Andrews
      • Greenville, South Carolina, United States, 29605
        • Greenville Health System Cancer Institute-Faris
      • Greenville, South Carolina, United States, 29605
        • Greenville Memorial Hospital
      • Greenville, South Carolina, United States, 29615
        • Greenville Health System Cancer Institute-Eastside
      • Greer, South Carolina, United States, 29651
        • Gibbs Cancer Center-Pelham
      • Greer, South Carolina, United States, 29650
        • Greenville Health System Cancer Institute-Greer
      • Seneca, South Carolina, United States, 29672
        • Greenville Health System Cancer Institute-Seneca
      • Spartanburg, South Carolina, United States, 29303
        • Spartanburg Medical Center
      • Spartanburg, South Carolina, United States, 29307
        • Greenville Health System Cancer Institute-Spartanburg
    • South Dakota
      • Aberdeen, South Dakota, United States, 57401
        • Avera Saint Luke's Hospital and Cancer Center
      • Sioux Falls, South Dakota, United States, 57105
        • Avera Cancer Institute
      • Sioux Falls, South Dakota, United States, 57104
        • Sanford Cancer Center Oncology Clinic
      • Sioux Falls, South Dakota, United States, 57117
        • Sanford USD Medical Center - Sioux Falls
    • Virginia
      • Charlottesville, Virginia, United States, 22901
        • Martha Jefferson Hospital
    • Washington
      • Aberdeen, Washington, United States, 98520
        • Providence Regional Cancer System-Aberdeen
      • Anacortes, Washington, United States, 98221
        • Cancer Care Center at Island Hospital
      • Bellevue, Washington, United States, 98005
        • Swedish Cancer Institute-Eastside Oncology Hematology
      • Bellingham, Washington, United States, 98225
        • PeaceHealth Saint Joseph Medical Center
      • Centralia, Washington, United States, 98531
        • Providence Regional Cancer System-Centralia
      • Edmonds, Washington, United States, 98026
        • Swedish Medical Center-Edmonds
      • Everett, Washington, United States, 98201
        • Providence Regional Cancer Partnership
      • Issaquah, Washington, United States, 98029
        • Swedish Medical Center - Issaquah
      • Lacey, Washington, United States, 98503
        • Providence Regional Cancer System-Lacey
      • Longview, Washington, United States, 98632
        • Saint John Medical Center
      • Seattle, Washington, United States, 98107
        • Swedish Medical Center-Ballard Campus
      • Seattle, Washington, United States, 98122
        • Swedish Medical Center-First Hill
      • Seattle, Washington, United States, 98104
        • Minor and James Medical PLLC
      • Seattle, Washington, United States, 98104
        • Pacific Gynecology Specialists
      • Seattle, Washington, United States, 98112
        • Group Health Cooperative-Seattle
      • Shelton, Washington, United States, 98548
        • Providence Regional Cancer System-Shelton
      • Spokane, Washington, United States, 99204
        • Rockwood Cancer Treatment Center-DHEC-Downtown
      • Spokane, Washington, United States, 99218
        • Evergreen Hematology and Oncology PS
      • Spokane Valley, Washington, United States, 99216
        • Rockwood Clinic Cancer Treatment Center-Valley
      • Vancouver, Washington, United States, 98664
        • PeaceHealth Southwest Medical Center
      • Walla Walla, Washington, United States, 99362
        • Providence Saint Mary Regional Cancer Center
      • Yakima, Washington, United States, 98902
        • North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
      • Yelm, Washington, United States, 98597
        • Providence Regional Cancer System-Yelm
    • Wisconsin
      • Chippewa Falls, Wisconsin, United States, 54729
        • Marshfield Clinic-Chippewa Center
      • Eau Claire, Wisconsin, United States, 54701
        • Marshfield Clinic Cancer Center at Sacred Heart
      • Eau Claire, Wisconsin, United States, 54701
        • Sacred Heart Hospital
      • Fond Du Lac, Wisconsin, United States, 54935
        • Saint Agnes Hospital/Agnesian Cancer Center
      • Green Bay, Wisconsin, United States, 54301
        • Green Bay Oncology at Saint Vincent Hospital
      • Green Bay, Wisconsin, United States, 54301
        • Saint Vincent Hospital
      • Green Bay, Wisconsin, United States, 54303
        • Green Bay Oncology Limited at Saint Mary's Hospital
      • Green Bay, Wisconsin, United States, 54303
        • Saint Mary's Hospital
      • La Crosse, Wisconsin, United States, 54601
        • Mayo Clinic Health System-Franciscan Healthcare
      • Manitowoc, Wisconsin, United States, 54221
        • Holy Family Memorial Hospital
      • Marinette, Wisconsin, United States, 54143
        • Bay Area Medical Center
      • Marshfield, Wisconsin, United States, 54449
        • Marshfield Clinic
      • Marshfield, Wisconsin, United States, 54449
        • Saint Joseph's Hospital
      • Minocqua, Wisconsin, United States, 54548
        • Marshfield Clinic-Minocqua Center
      • New Richmond, Wisconsin, United States, 54017
        • Westfields Hospital/Cancer Center of Western Wisconsin
      • Oconto Falls, Wisconsin, United States, 54154
        • Green Bay Oncology - Oconto Falls
      • Rhinelander, Wisconsin, United States, 54501
        • Marshfield Clinic at James Beck Cancer Center
      • Rice Lake, Wisconsin, United States, 54868
        • Marshfield Clinic-Rice Lake Center
      • Sheboygan, Wisconsin, United States, 53081
        • Saint Nicholas Hospital
      • Stevens Point, Wisconsin, United States, 54481
        • Marshfield Clinic at Saint Michael's Hospital
      • Stevens Point, Wisconsin, United States, 54481
        • Saint Michael's Hospital
      • Sturgeon Bay, Wisconsin, United States, 54235-1495
        • Door County Cancer Center
      • Sturgeon Bay, Wisconsin, United States, 54235
        • Green Bay Oncology - Sturgeon Bay
      • Wausau, Wisconsin, United States, 54401
        • Marshfield Clinic-Wausau Center
      • Weston, Wisconsin, United States, 54476
        • Diagnostic and Treatment Center
      • Weston, Wisconsin, United States, 54476
        • Marshfield Clinic - Weston Center
      • Weston, Wisconsin, United States, 54476
        • Saint Clare's Hospital
      • Wisconsin Rapids, Wisconsin, United States, 54494
        • Marshfield Clinic - Wisconsin Rapids Center
    • Wyoming
      • Cheyenne, Wyoming, United States, 82001
        • Cheyenne Regional Medical Center-West

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  1. Documentation of Disease: Histologic documentation of malignancy currently undergoing a course of RT (with or without chemotherapy) including the oral cavity and/or oropharyngeal area to a dose of at least 4500 cGy using more than 5 fractions (i.e., stereotactic body radiation therapy [SBRT] is not allowed).
  2. Physical exam demonstrating evidence of radiotherapy-related mucositis in the visible oral cavity and/or oropharynx consistent with mucous membrane toxicity greater than 0 using the Acute Radiation Morbidity Scoring Criteria.
  3. At least 4 (out of 10) patient-reported oral pain related to oral mucositis secondary to RT for which the patient seeks relief, as measured on the Oral Pain Assessment.

    Note: The pain score must be at least 4 at the time that the patient starts the first dose of study medication. The patient may be enrolled to the study if s/he, at times, has a pain score of at least 4, so long as initiation of study treatment begins when the pain score is at least 4.

  4. Ability to complete questionnaire(s) by themselves or with assistance.
  5. No known allergy to diphenhydramine, lidocaine, antacid (aluminum hydroxide, magnesium hydroxide, and simethicone), doxepin, tricyclic antidepressants, or any known component of the drug formulation in the testing arms.
  6. No use of any anti-arrhythmic medication (except for beta-blockers) including lidocaine, linezolid, ipratropium, or medications with high anti-cholinergic potency (including neostigmine, a tricyclic antidepressant or a monoamine oxidase inhibitor) within 2 weeks prior to registration.
  7. No current diagnosed untreated or unresolved oral candidiasis or oral HSV infection.
  8. No history of untreated narrow angle glaucoma within 6 weeks prior to registration.
  9. No untreated urinary retention within 6 weeks prior to registration.
  10. No current use of glutamine or sucralfate powders at the time of registration (no washout required).
  11. No cryotherapy for prophylactic mucosal protection within 6 weeks prior to registration.
  12. Not pregnant, because patients eligible for this study will be receiving radiotherapy, which has known genotoxic, mutagenic and teratogenic effects. Therefore, for women of childbearing potential only, a negative pregnancy test done ≤ 28 days prior to registration is required.
  13. Age ≥ 18 years
  14. ECOG Performance Status 0, 1, or 2

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: doxepin rinse

Patients receive 2.5 mL (25 mg) doxepin and 2.5 mL water orally. Doxepin rinse is administered in the clinic on Day 1 (Cycle 1). There is an optional continuation phase within seven days following Day 1 (Cycle 1), patients will be encouraged to continue treatment with the study agent for an additional week (Cycle 2) where the patient takes the rinse at home every 4 hours. Chemotherapy is allowed during the continuation phase. Patients randomized to doxepin or placebo, they and their caregivers will continue to be blinded to the treatment.

Patients will complete the Oral Symptoms booklet per the protocol.

2.5 mL (25 mg) doxepin and 2.5 mL water administered orally
Active Comparator: DLA (diphenhydramine, lidocaine and antacid) rinse

Patients receive 5.0 mL DLA orally. DLA is administered in the clinic on Day 1 (Cycle 1). There is an optional continuation phase within seven days following Day 1 (Cycle 1), patients will be encouraged to continue treatment with the study agent for an additional week (Cycle 2) where the patient takes the rinse at home every 4 hours. Chemotherapy is allowed during the continuation phase. Patients receiving DLA during the continuation phase of the study, they and/or caregivers may be aware that they are receiving DLA.

Patients will complete the Oral Symptoms booklet per the protocol.

5.0 mL administered orally
Placebo Comparator: placebo rinse

Patients receive 2.5 mL placebo and 2.5 mL water orally. The placebo rinse is administered in the clinic on Day 1 (Cycle 1). There is an optional continuation phase within seven days following Day 1 (Cycle 1), patients will be encouraged to continue treatment with the study agent for an additional week (Cycle 2) where the patient takes the rinse at home every 4 hours. Chemotherapy is allowed during the continuation phase. Patients randomized to doxepin or placebo, they and their caregivers will continue to be blinded to the treatment.

Patients will complete the Oral Symptoms booklet per the protocol.

2.5 mL placebo and 2.5 mL water administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Area Under the Curve (AUC) of Total Pain Reduction
Time Frame: Baseline, 5, 15, 30, 60, 120, 240 minutes post treatment
Total pain reduction (mouth and throat) was measured by the numerical analogue scale of mouth pain on a scale of 0 to 10, with 0=no pain and 10=worst pain in the questionnaires taken at baseline, and 5, 15, 30, 60, 120, 240 minutes after assigned treatment for doxepin or DLA vs. placebo. The total pain reduction was calculated by the (average of mouth and throat) area under the curve (AUC) adjusting for baseline, with time scale (baseline, 5, 15, 30, 60, 120 and 240 minutes post treatment) replaced by a numerical scale of 0, 1, 2, 3, 4, 5 and 6 respectively. The AUC was prorated when there are terminal missing data. If the missing data were intermittent, simple imputation by trapezoidal rules were applied to calculate the AUC. If a patient cancelled, was missing baseline data, or only provided baseline data, he/she was excluded from the statistical analysis.
Baseline, 5, 15, 30, 60, 120, 240 minutes post treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
The Total Unpleasant Taste of the Oral Rinse as Measured by the Numerical Analogue Scale of Taste of the Oral Rinse in the Questionnaires
Time Frame: Up to 4 hours post-treatment
Up to 4 hours post-treatment
The Total Stinging or Burning From the Oral Rinse as Measured by the Numerical Analogue Scale of Stinging or Burning From the Oral Rinse in the Questionnaires
Time Frame: Up to 4 hours post-treatment
Up to 4 hours post-treatment
The Total Drowsiness Increase as Measured by the Numerical Analogue Scale of Drowsiness Questionnaires
Time Frame: Up to 4 hours post-treatment every 4 hours while on treatment
Up to 4 hours post-treatment every 4 hours while on treatment
The Incidence of Using Alternative Analgesics Between 1 and 4 Hours After Initial Mouthwash
Time Frame: Up to 4 hours post-treatment
Up to 4 hours post-treatment
Patient Preference for Continued Therapy With Oral Rinse After Initial Test Rinse Phase, as Measured by Item 9 in the Patient-reported Questionnaire After 4 Hours
Time Frame: Up to 4 hours post-treatment
Up to 4 hours post-treatment
The Length of Time in the Continuation Phase
Time Frame: Up to 4 hours post-treatment
Up to 4 hours post-treatment
Pain Score in the Continuation Phase
Time Frame: Up to 4 hours post-treatment
Up to 4 hours post-treatment
Alternative Analgesics Use in the Continuation Phase
Time Frame: Up to 4 hours post-treatment
Up to 4 hours post-treatment

Collaborators and Investigators

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

Investigators

  • Study Chair: Robert Miller, MD, MS, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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)

November 1, 2014

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

March 15, 2019

Study Registration Dates

First Submitted

August 29, 2014

First Submitted That Met QC Criteria

August 29, 2014

First Posted (Estimate)

September 1, 2014

Study Record Updates

Last Update Posted (Actual)

October 16, 2019

Last Update Submitted That Met QC Criteria

October 4, 2019

Last Verified

October 1, 2019

More Information

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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