Gabapentin in Preventing Nausea and Vomiting in Patients Receiving Chemotherapy

July 1, 2016 updated by: Alliance for Clinical Trials in Oncology

Phase III Double-Blind, Placebo-Controlled Study of Gabapentin for the Prevention of Delayed CINV (Chemotherapy Induced Nausea and Vomiting) in Patients Receiving Highly Emetogenic Chemotherapy

RATIONALE: Gabapentin may prevent or reduce delayed nausea and vomiting caused by chemotherapy. It is not yet known whether gabapentin is more effective than a placebo in preventing nausea and vomiting.

PURPOSE: This randomized phase III trial is studying the side effects of gabapentin and to see how well it works compared with a placebo in preventing nausea and vomiting in patients receiving chemotherapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

To evaluate the effectiveness of gabapentin in controlling delayed chemotherapy-induced nausea and vomiting (CINV) in patients receiving highly emetogenic chemotherapy as defined by the percentage of complete responders (no emetic episodes and no rescue medication) on days 2 through 6 (five days after receipt of highly emetogenic chemotherapy) compared to an effective prophylactic regimen.
To evaluate the effectiveness of gabapentin in controlling delayed CINV in patients receiving highly emetogenic chemotherapy as defined by the percentage of complete responders (no emetic episodes, no more than mild nausea, and no rescue medication) on days 2 through 6 compared to an effective prophylactic regimen.
To compare the effectiveness of these regimens in controlling acute CINV on day 1 of treatment in these patients.
To compare the use of rescue agents in these patients.
To determine the tolerability of gabapentin in these patients.
To evaluate the effect of gabapentin for delayed chemotherapy-induced nausea and vomiting on symptom distress and functional abilities in these patients.
To compare alternative endpoints and methods for assessing nausea and vomiting and to determine how these measures compare to patient's satisfaction with symptom control, distress and function.

OUTLINE: This is a multicenter study. Patients are stratified according to gender, age (< 50 years vs > 50 years), history of alcoholism (yes vs no), and history of motion sickness or history of pregnancy induced nausea/vomiting (yes vs no). Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral gabapentin once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral gabapentin either two or three times daily on days 2-5 of chemotherapy.
Arm II: Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral placebo once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral placebo either two or three times daily on days 2-5 of chemotherapy.

Patients complete a Functional Living Index - Emesis questionnaire, an overall satisfaction survey, and a side effect experience diary at baseline and on day 6. Patients also complete a nausea and vomiting diary at baseline and periodically during study therapy.

Study Type

Interventional

Enrollment (Actual)

430

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

United States
- Arizona
  - Scottsdale, Arizona, United States, 85259-5499
    - Mayo Clinic Scottsdale
- Colorado
  - Aurora, Colorado, United States, 80012
    - Aurora Presbyterian Hospital
  - Boulder, Colorado, United States, 80301-9019
    - Boulder Community Hospital
  - Colorado Springs, Colorado, United States, 80933
    - Penrose Cancer Center at Penrose Hospital
  - Denver, Colorado, United States, 80210
    - Porter Adventist Hospital
  - Denver, Colorado, United States, 80220
    - Rose Medical Center
  - Denver, Colorado, United States, 80218
    - Presbyterian - St. Luke's Medical Center
  - Denver, Colorado, United States, 80204
    - St. Anthony Central Hospital
  - Denver, Colorado, United States, 80218
    - St. Joseph Hospital
  - Denver, Colorado, United States, 80224-2522
    - CCOP - Colorado Cancer Research Program
  - Englewood, Colorado, United States, 80110
    - Swedish Medical Center
  - Fort Collins, Colorado, United States, 80524
    - Poudre Valley Hospital
  - Fort Collins, Colorado, United States, 80528
    - Front Range Cancer Specialists
  - Grand Junction, Colorado, United States, 81502
    - St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
  - Greeley, Colorado, United States, 80631
    - North Colorado Medical Center
  - Lone Tree, Colorado, United States, 80124
    - Sky Ridge Medical Center
  - Longmont, Colorado, United States, 80501
    - Hope Cancer Care Center at Longmont United Hospital
  - Loveland, Colorado, United States, 80539
    - McKee Medical Center
  - Pueblo, Colorado, United States, 81004
    - St. Mary - Corwin Regional Medical Center
  - Thornton, Colorado, United States, 80229
    - North Suburban Medical Center
  - Wheat Ridge, Colorado, United States, 80033
    - Exempla Lutheran Medical Center
- Connecticut
  - Hartford, Connecticut, United States, 06105
    - Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
- Florida
  - Jacksonville, Florida, United States, 32224
    - Mayo Clinic - Jacksonville
- Georgia
  - Augusta, Georgia, United States, 30912
    - MBCCOP - Medical College of Georgia Cancer Center
- Illinois
  - Aurora, Illinois, United States, 60504
    - Rush-Copley Cancer Care Center
  - Bloomington, Illinois, United States, 61701
    - St. Joseph Medical Center
  - Bloomington%, Illinois, United States, 61701
    - Illinois CancerCare - Bloomington
  - Canton, Illinois, United States, 61520
    - Illinois CancerCare - Canton
  - Canton, Illinois, United States, 61520
    - Graham Hospital
  - Carthage, Illinois, United States, 62321
    - Memorial Hospital
  - Carthage, Illinois, United States, 62321
    - Illinois CancerCare - Carthage
  - Eureka, Illinois, United States, 61530
    - Illinois CancerCare - Eureka
  - Eureka, Illinois, United States, 61530
    - Eureka Community Hospital
  - Galesburg, Illinois, United States, 61401
    - Illinois CancerCare - Galesburg
  - Galesburg, Illinois, United States, 61401
    - Galesburg Clinic, PC
  - Havana, Illinois, United States, 62644
    - Mason District Hospital
  - Havana, Illinois, United States, 62644
    - Illinois CancerCare - Havana
  - Kewanee, Illinois, United States, 61443
    - Illinois CancerCare - Kewanee Clinic
  - Macomb, Illinois, United States, 61455
    - Illinois CancerCare - Macomb
  - Macomb, Illinois, United States, 61455
    - Mcdonough District Hospital
  - Moline, Illinois, United States, 61265
  - Moline, Illinois, United States, 61265
    - Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
  - Monmouth, Illinois, United States, 61462
    - Illinois CancerCare - Monmouth
  - Normal, Illinois, United States, 61761
    - Bromenn Regional Medical Center
  - Normal, Illinois, United States, 61761
    - Community Cancer Center
  - Normal, Illinois, United States, 61761
    - Illinois CancerCare - Community Cancer Center
  - Ottawa, Illinois, United States, 61350
    - Community Hospital of Ottawa
  - Ottawa, Illinois, United States, 61350
    - Oncology Hematology Associates of Central Illinois, PC - Ottawa
  - Pekin, Illinois, United States, 61554
    - Cancer Treatment Center at Pekin Hospital
  - Pekin, Illinois, United States, 61603
    - Illinois CancerCare - Pekin
  - Peoria, Illinois, United States, 61636
    - Methodist Medical Center of Illinois
  - Peoria, Illinois, United States, 61614
    - Proctor Hospital
  - Peoria, Illinois, United States, 61637
    - OSF St. Francis Medical Center
  - Peoria, Illinois, United States, 61615
    - CCOP - Illinois Oncology Research Association
  - Peoria, Illinois, United States, 61615
    - Oncology Hematology Associates of Central Illinois, PC - Peoria
  - Peru, Illinois, United States, 61354
    - Illinois CancerCare - Peru
  - Peru, Illinois, United States, 61354
    - Illinois Valley Community Hospital
  - Princeton, Illinois, United States, 61356
    - Perry Memorial Hospital
  - Princeton, Illinois, United States, 61356
    - Illinois CancerCare - Princeton
  - Spring Valley, Illinois, United States, 61362
    - Illinois CancerCare - Spring Valley
  - Urbana, Illinois, United States, 61801
    - CCOP - Carle Cancer Center
- Indiana
  - Beech Grove, Indiana, United States, 46107
    - St. Francis Hospital and Health Centers - Beech Grove Campus
  - Elkhart, Indiana, United States, 46515
    - Elkhart General Hospital
  - Elkhart, Indiana, United States, 46514-2098
    - Elkhart Clinic, LLC
  - Elkhart, Indiana, United States, 46514
    - Michiana Hematology-Oncology, PC - Elkhart
  - Kokomo, Indiana, United States, 46904
    - Howard Community Hospital
  - La Porte, Indiana, United States, 46350
    - Center for Cancer Therapy at LaPorte Hospital and Health Services
  - Michigan City, Indiana, United States, 46360
    - Saint Anthony Memorial Health Centers
  - Mishawaka, Indiana, United States, 46545-1470
    - Michiana Hematology-Oncology, PC - South Bend
  - Mishawaka, Indiana, United States, 46545-1470
    - Saint Joseph Regional Medical Center
  - Plymouth, Indiana, United States, 46563
    - Michiana Hematology Oncology PC - Plymouth
  - Richmond, Indiana, United States, 47374
    - Reid Hospital & Health Care Services
  - South Bend, Indiana, United States, 46601
    - Memorial Hospital of South Bend
  - South Bend, Indiana, United States, 46601
    - CCOP - Northern Indiana CR Consortium
  - South Bend, Indiana, United States, 46617
    - South Bend Clinic
  - Westville, Indiana, United States, 46391
    - Michiana Hematology Oncology PC - La Porte
- Iowa
  - Ames, Iowa, United States, 50010
    - McFarland Clinic, PC
  - Bettendorf, Iowa, United States, 52722
  - Clive, Iowa, United States, 50325
    - Medical Oncology and Hematology Associates - West Des Moines
  - Des Moines, Iowa, United States, 50309
    - CCOP - Iowa Oncology Research Association
  - Des Moines, Iowa, United States, 50309
    - John Stoddard Cancer Center at Iowa Methodist Medical Center
  - Des Moines, Iowa, United States, 50309
    - Medical Oncology and Hematology Associates at John Stoddard Cancer Center
  - Des Moines, Iowa, United States, 50314
    - Medical Oncology and Hematology Associates at Mercy Cancer Center
  - Des Moines, Iowa, United States, 50314
    - Mercy Cancer Center at Mercy Medical Center - Des Moines
  - Des Moines, Iowa, United States, 50316
    - John Stoddard Cancer Center at Iowa Lutheran Hospital
  - Sioux City, Iowa, United States, 51101
    - Siouxland Hematology-Oncology Associates, LLP
  - Sioux City, Iowa, United States, 51104
    - St. Luke's Regional Medical Center
  - Sioux City, Iowa, United States, 51104
    - Mercy Medical Center - Sioux City
- Kansas
  - Chanute, Kansas, United States, 66720
    - Cancer Center of Kansas, PA - Chanute
  - Dodge City, Kansas, United States, 67801
    - Cancer Center of Kansas, PA - Dodge City
  - El Dorado, Kansas, United States, 67042
    - Cancer Center of Kansas, PA - 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, PA - Kingman
  - Lawrence, Kansas, United States, 66044
    - Lawrence Memorial Hospital
  - Liberal, Kansas, United States, 67905
    - Cancer Center of Kansas, PA - Liberal
  - Newton, Kansas, United States, 67114
    - Cancer Center of Kansas, PA - Newton
  - Parsons, Kansas, United States, 67357
    - Cancer Center of Kansas, PA - Parsons
  - Pratt, Kansas, United States, 67124
    - Cancer Center of Kansas, PA - Pratt
  - Salina, Kansas, United States, 67401
    - Cancer Center of Kansas, PA - Salina
  - Wellington, Kansas, United States, 67152
    - Cancer Center of Kansas, PA - Wellington
  - Wichita, Kansas, United States, 67208
    - Cancer Center of Kansas, PA - Medical Arts Tower
  - Wichita, Kansas, United States, 67214
    - Cancer Center of Kansas, PA - Wichita
  - Wichita, Kansas, United States, 67214
    - CCOP - Wichita
  - Wichita, Kansas, United States, 67214
    - Via Christi Cancer Center at Via Christi Regional Medical Center
  - Winfield, Kansas, United States, 67156
    - Cancer Center of Kansas, PA - Winfield
- Michigan
  - Adrian, Michigan, United States, 49221
    - Hickman Cancer Center at Bixby Medical Center
  - Ann Arbor, Michigan, United States, 48106-0995
    - Saint Joseph Mercy Cancer Center
  - Ann Arbor, Michigan, United States, 48106
    - CCOP - Michigan Cancer Research Consortium
  - Dearborn, Michigan, United States, 48123-2500
    - Oakwood Cancer Center at Oakwood Hospital and Medical Center
  - Escanaba, Michigan, United States, 49431
    - Green Bay Oncology, Limited - Escanaba
  - Flint, Michigan, United States, 48503
    - Hurley Medical Center
  - Flint, Michigan, United States, 48503
    - Genesys Hurley Cancer Institute
  - Grosse Pointe Woods, Michigan, United States, 48236
    - Van Elslander Cancer Center at St. John Hospital and Medical Center
  - Iron Mountain, Michigan, United States, 49801
    - Dickinson County Healthcare System
  - Jackson, Michigan, United States, 49201
    - Foote Memorial Hospital
  - Lambertville, Michigan, United States, 48144
    - Haematology-Oncology Associates of Ohio and Michigan, PC
  - Lansing, Michigan, United States, 48912-1811
    - Sparrow Regional Cancer Center
  - Livonia, Michigan, United States, 48154
    - St. Mary Mercy Hospital
  - Monroe, Michigan, United States, 48162
    - Community Cancer Center of Monroe
  - Monroe, Michigan, United States, 48162
    - Mercy Memorial Hospital - Monroe
  - Niles, Michigan, United States, 49120
    - Michiana Hematology Oncology PC - Niles
  - Pontiac, Michigan, United States, 48341-2985
    - St. Joseph Mercy Oakland
  - Port Huron, Michigan, United States, 48060
    - Mercy Regional Cancer Center at Mercy Hospital
  - Saginaw, Michigan, United States, 48601
    - Seton Cancer Institute at Saint Mary's - Saginaw
  - Saint Joseph, Michigan, United States, 49085
    - Lakeside Cancer Specialists, PLLC
  - St. Joseph, Michigan, United States, 49085
    - Lakeland Regional Cancer Care Center - St. Joseph
  - Warren, Michigan, United States, 48093
    - St. John Macomb Hospital
- Minnesota
  - Alexandria, Minnesota, United States, 56308
  - Bemidji, Minnesota, United States, 56601
    - MeritCare Bemidji
  - Burnsville, Minnesota, United States, 55337
    - Fairview Ridges Hospital
  - Coon Rapids, Minnesota, United States, 55433
    - Mercy and Unity Cancer Center at Mercy Hospital
  - Duluth, Minnesota, United States, 55805
    - CCOP - Duluth
  - Duluth, Minnesota, United States, 55805-1983
    - Duluth Clinic Cancer Center - Duluth
  - Duluth, Minnesota, United States, 55805
    - Miller - Dwan Medical Center
  - Edina, Minnesota, United States, 55435
    - Fairview Southdale Hospital
  - Fergus Falls, Minnesota, United States, 56537
    - Fergus Falls Medical Group, PA
  - Fridley, Minnesota, United States, 55432
    - Mercy and Unity Cancer Center at Unity Hospital
  - Hutchinson, Minnesota, United States, 55350
    - Hutchinson Area Health Care
  - Mankato, Minnesota, United States, 56002
    - Immanuel St. Joseph's
  - Maplewood, Minnesota, United States, 55109
    - Minnesota Oncology Hematology, PA - Maplewood
  - Maplewood, Minnesota, United States, 55109
    - HealthEast Cancer Care at St. John's Hospital
  - Minneapolis, Minnesota, United States, 55407
    - Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
  - Minneapolis, Minnesota, United States, 55415
    - Hennepin County Medical Center - Minneapolis
  - Robbinsdale, Minnesota, United States, 55422-2900
    - Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
  - Rochester, Minnesota, United States, 55905
    - Mayo Clinic Cancer Center
  - Saint Cloud, Minnesota, United States, 56303
    - CentraCare Clinic - River Campus
  - Saint Cloud, Minnesota, United States, 56303
    - Coborn Cancer Center
  - Saint Louis Park, Minnesota, United States, 55416
    - CCOP - Metro-Minnesota
  - Saint Louis Park, Minnesota, United States, 55416
    - Park Nicollet Cancer Center
  - Saint Paul, Minnesota, United States, 55102
    - United Hospital
  - Shakopee, Minnesota, United States, 55379
    - St. Francis Cancer Center at St. Francis Medical Center
  - St. Paul, Minnesota, United States, 55101
    - Regions Hospital Cancer Care Center
  - Waconia, Minnesota, United States, 55387
    - Ridgeview Medical Center
  - Willmar, Minnesota, United States, 56201
    - Willmar Cancer Center at Rice Memorial Hospital
  - Woodbury, Minnesota, United States, 55125
    - Minnesota Oncology Hematology, PA - Woodbury
- Missouri
  - Saint Louis, Missouri, United States, 63131
    - Missouri Baptist Cancer Center
  - Saint Louis, Missouri, United States, 63141
    - Arch Medical Services, Incorporated at Center for Cancer Care and Research
  - Saint Louis, Missouri, United States, 63141
    - Comprehensive Cancer Care, PC
- Nebraska
  - Lincoln, Nebraska, United States, 68510
    - Cancer Resource Center - Lincoln
  - Omaha, Nebraska, United States, 68106
    - CCOP - Missouri Valley Cancer Consortium
  - Omaha, Nebraska, United States, 68122
    - Immanuel Medical Center
  - Omaha, Nebraska, United States, 68124
    - Alegant Health Cancer Center at Bergan Mercy Medical Center
  - Omaha, Nebraska, United States, 68131-2197
    - Creighton University Medical Center
- New Mexico
  - Albuquerque, New Mexico, United States, 87131-5636
    - University of New Mexico Cancer Center
  - Albuquerque, New Mexico, United States, 87102
    - Lovelace Medical Center - Downtown
- North Carolina
  - Rutherfordton, North Carolina, United States, 28139
    - Rutherford Hospital
- North Dakota
  - Bismarck, North Dakota, United States, 58501
    - Bismarck Cancer Center
  - Bismarck, North Dakota, United States, 58501
    - Medcenter One Hospital Cancer Care Center
  - Bismarck, North Dakota, United States, 58501
    - Mid Dakota Clinic, PC
  - Bismarck, North Dakota, United States, 58502
    - St. Alexius Medical Center Cancer Center
  - Fargo, North Dakota, United States, 58122
    - CCOP - MeritCare Hospital
  - Fargo, North Dakota, United States, 58122
    - MeritCare Broadway
  - Grand Forks, North Dakota, United States, 58201
    - Altru Cancer Center at Altru Hospital
- Ohio
  - Bellefontaine, Ohio, United States, 43311
    - Mary Rutan Hospital
  - Bowling Green, Ohio, United States, 43402
    - Wood County Oncology Center
  - Chillicothe, Ohio, United States, 45601
    - Adena Regional Medical Center
  - Clyde, Ohio, United States, 43410
    - North Coast Cancer Care - Clyde
  - Columbus, Ohio, United States, 43214-3998
    - Riverside Methodist Hospital Cancer Care
  - Columbus, Ohio, United States, 43222
    - Mount Carmel Health - West Hospital
  - Columbus, Ohio, United States, 43215
    - CCOP - Columbus
  - Columbus, Ohio, United States, 43215
    - Grant Medical Center Cancer Care
  - Columbus, Ohio, United States, 43228
    - Doctors Hospital at Ohio Health
  - Dayton, Ohio, United States, 45405
    - Grandview Hospital
  - Dayton, Ohio, United States, 45406
    - Good Samaritan Hospital
  - Dayton, Ohio, United States, 45409
    - David L. Rike Cancer Center at Miami Valley Hospital
  - Dayton, Ohio, United States, 45415
    - Samaritan North Cancer Care Center
  - Dayton, Ohio, United States, 45420
    - CCOP - Dayton
  - Delaware, Ohio, United States, 43015
    - Grady Memorial Hospital
  - Elyria, Ohio, United States, 44035
    - Community Cancer Center
  - Elyria, Ohio, United States, 44035
    - Hematology Oncology Center
  - Findlay, Ohio, United States, 45840
    - Blanchard Valley Medical Associates
  - Franklin, Ohio, United States, 45005-1066
    - Middletown Regional Hospital
  - Greenville, Ohio, United States, 45331
    - Wayne Hospital
  - Kettering, Ohio, United States, 45429
    - Charles F. Kettering Memorial Hospital
  - Lancaster, Ohio, United States, 43130
    - Fairfield Medical Center
  - Lima, Ohio, United States, 45804
    - Lima Memorial Hospital
  - Marietta, Ohio, United States, 45750
    - Strecker Cancer Center at Marietta Memorial Hospital
  - Maumee, Ohio, United States, 43537
    - St. Luke's Hospital
  - Maumee, Ohio, United States, 43537-1839
    - Northwest Ohio Oncology Center
  - Mount Vernon, Ohio, United States, 43050
    - Knox Community Hospital
  - Newark, Ohio, United States, 43055
    - Licking Memorial Cancer Care Program at Licking Memorial Hospital
  - Norwalk, Ohio, United States, 44857
    - Fisher-Titus Medical Center
  - Oregon, Ohio, United States, 43616
    - St. Charles Mercy Hospital
  - Oregon, Ohio, United States, 43616
    - Toledo Clinic - Oregon
  - Sandusky, Ohio, United States, 44870
    - North Coast Cancer Care, Incorporated
  - Springfield, Ohio, United States, 45505
    - Community Hospital of Springfield and Clark County
  - Sylvania, Ohio, United States, 43560
    - Flower Hospital Cancer Center
  - Tiffin, Ohio, United States, 44883
    - Mercy Hospital of Tiffin
  - Toledo, Ohio, United States, 43608
    - St. Vincent Mercy Medical Center
  - Toledo, Ohio, United States, 43606
    - Toledo Hospital
  - Toledo, Ohio, United States, 43614
    - Medical University of Ohio Cancer Center
  - Toledo, Ohio, United States, 43617
    - CCOP - Toledo Community Hospital
  - Toledo, Ohio, United States, 43623
    - Toledo Clinic, Incorporated - Main Clinic
  - Toledo, Ohio, United States, 43623
    - St. Anne Mercy Hospital
  - Troy, Ohio, United States, 45373-1300
    - UVMC Cancer Care Center at Upper Valley Medical Center
  - Wauseon, Ohio, United States, 43567
    - Fulton County Health Center
  - Westerville, Ohio, United States, 43081
    - Mount Carmel St. Ann's Cancer Center
  - Wilmington, Ohio, United States, 45177
    - Clinton Memorial Hospital
  - Wright-Patterson Afb, Ohio, United States, 45433-5529
    - United States Air Force Medical Center - Wright-Patterson
  - Xenia, Ohio, United States, 45385
    - Ruth G. McMillan Cancer Center at Greene Memorial Hospital
  - Zanesville, Ohio, United States, 43701
    - Genesis - Good Samaritan Hospital
- Oklahoma
  - Tulsa, Oklahoma, United States, 74136
    - Natalie Warren Bryant Cancer Center at St. Francis Hospital
- South Carolina
  - Anderson, South Carolina, United States, 29621
    - AnMed Cancer Center
  - Spartanburg, South Carolina, United States, 29303
    - CCOP - Upstate Carolina
  - Spartanburg, South Carolina, United States, 29303
    - Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
- South Dakota
  - Sioux Falls, South Dakota, United States, 57105
    - Medical X-Ray Center, PC
  - Sioux Falls, South Dakota, United States, 57117-5039
    - Sanford Cancer Center at Sanford USD Medical Center
- Virginia
  - Fredericksburg, Virginia, United States, 22401
    - Fredericksburg Oncology, Incorporated
  - Richmond, Virginia, United States, 23298-0037
    - Virginia Commonwealth University Massey Cancer Center
- Wisconsin
  - Chippewa Falls, Wisconsin, United States, 54729
    - Marshfield Clinic - Chippewa Center
  - Eau Claire, Wisconsin, United States, 54701
    - Marshfield Clinic Cancer Care at Regional Cancer Center
  - Green Bay, Wisconsin, United States, 54307-3508
    - St. Vincent Hospital Regional Cancer Center
  - Green Bay, Wisconsin, United States, 54301-3526
    - Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
  - Green Bay, Wisconsin, United States, 54303
    - Green Bay Oncology, Limited at St. Mary's Hospital
  - Green Bay, Wisconsin, United States, 54303
    - St. Mary's Hospital Medical Center - Green Bay
  - Manitowoc, Wisconsin, United States, 54221-1450
    - Holy Family Memorial Medical Center Cancer Care Center
  - Marinette, Wisconsin, United States, 54143
    - Bay Area Cancer Care Center at Bay Area Medical Center
  - Marshfield, Wisconsin, United States, 54449
    - Marshfield Clinic - Marshfield Center
  - Minocqua, Wisconsin, United States, 54548
    - Marshfield Clinic - Lakeland Center
  - Oconto Falls, Wisconsin, United States, 54154
    - Green Bay Oncology, Limited - Oconto Falls
  - Rhinelander, Wisconsin, United States, 54501
    - Ministry Medical Group at Saint Mary's Hospital
  - Rice Lake, Wisconsin, United States, 54868
    - Marshfield Clinic - Indianhead Center
  - Stevens Point, Wisconsin, United States, 54481
    - Marshfield Clinic at Saint Michael's Hospital
  - Sturgeon Bay, Wisconsin, United States, 54235
    - Green Bay Oncology, Limited - Sturgeon Bay
  - Weston, Wisconsin, United States, 54476
    - Marshfield Clinic - Weston Center
  - Wisconsin Rapids, Wisconsin, United States, 54494
    - Marshfield Clinic - Wisconsin Rapids Center

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

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

Scheduled to receive highly emetogenic chemotherapy
- May be scheduled to receive prophylactic treatment for acute nausea and vomiting with a 5HT3 antagonist and dexamethasone 20 mg on day 1 of chemotherapy treatment
- May be scheduled to receive multiple day chemotherapy regimens as long as the chemotherapy drugs given on the subsequent days have mild or no emetogenic potential
Chemotherapy schedules must allow at least 7 days rest between courses involving administration of highly emetogenic chemotherapy
No primary CNS malignancy and/or CNS metastasis

PATIENT CHARACTERISTICS:

Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Life expectancy ≥ 3 months
Creatinine ≤ 1.5 times upper limit of normal within the past 30 days
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
Ability to complete questionnaire(s) by his/herself or with assistance
Able to swallow pills
No epilepsy or seizure history
No gastrointestinal obstruction, active peptic ulcer disease, or uncontrolled heartburn
No history of nausea and/or vomiting related to any kind of chemotherapy
No nausea or vomiting within the past 3 days
No history of allergic or other adverse reaction to gabapentin or pregabalin

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
No prior moderate or highly emetogenic chemotherapy
No prior or concurrent aprepitant or any other NK-1 receptor antagonist
At least 1 months since prior and no concurrent gabapentin, pregabalin, or other anticonvulsants
At least 7 days since prior and no concurrent pelvic or abdominal radiotherapy
At least 3 days since prior antiemetics
No concurrent or planned use of lorazepam, diphenhydramine, eszopiclone, and/or dronabinol during the 6 days of this study, except for treatment of breakthrough nausea and vomiting

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: Double

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm I Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral gabapentin once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral gabapentin either two or three times daily on days 2-5 of chemotherapy.	Drug: dexamethasone Given orally Drug: gabapentin Given orally
Experimental: Arm II Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral placebo once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral placebo either two or three times daily on days 2-5 of chemotherapy.	Drug: dexamethasone Given orally Other: placebo Given orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of Percentage of Complete Responders Time Frame: Days 2 through 6	Complete response being defined as no emetic episodes and no use of rescue therapy for days 2 through 6. If a patient does not complete the study or does not provide complete data, they will be assumed to be a non-responder.	Days 2 through 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete Response Time Frame: Days 2-6	The primary analysis described above was repeated using a slightly different alternate definition of complete response: no emetic episodes, no more than a mean of 2.5 on the nausea numeric analogue scale (0 - 10 (As bad as it could be)), and no rescue agents.	Days 2-6
Comparison of Percentages of Complete Responders on Day 1, vs. Days 1 Through 6 vs. Days 2 Through 6. Time Frame: Days 1 through 6	The percentages of complete responders on day 1, vs. days 1 through 6 vs. days 2 through 6 will be compared between arms. Complete response being defined as no emetic episodes and no use of rescue therapy. If a patient does not complete the study or does not provide complete data, they will be assumed to be a non-responder.	Days 1 through 6
Comparison of the Percentage of Patients Experiencing Emetic Episodes and the Percentage Needing Rescue Agents Time Frame: Days1 through 6	The percentage of patients experiencing emetic episodes and the percentage needing rescue agents was compared between groups.	Days1 through 6
Comparison of Sum of the Daily Distress Questions as Well as the Individual Daily Responses Time Frame: Days 1 through 6	The sum of the daily distress questions as well as the individual daily responses from the Nausea and Vomiting Diary (NVD) on a 0-10 scale (Lower score is better) will be compared.	Days 1 through 6
Level of Satisfaction for the Control of Nausea. Time Frame: Days 1 through 6	Level of satisfaction for the control of nausea with the mean severity of nausea over the six days in the diary (on a 0 - 10 scale, higher the better) as well as the nausea subscale on the Functional Living Index - Emesis (FLIE) questionnaire ( 1-7 scale, lower the better)	Days 1 through 6
Comparison of Daily Complete Response Endpoints Time Frame: Days 1 through 6	Daily complete response is defined as no emetic episodes and no use of rescue therapy.	Days 1 through 6

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

April 1, 2009

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

April 10, 2009

First Submitted That Met QC Criteria

April 10, 2009

First Posted (Estimate)

April 13, 2009

Study Record Updates

Last Update Posted (Estimate)

July 6, 2016

Last Update Submitted That Met QC Criteria

July 1, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

NCCTG-N08C3
NCI-2009-01110 (Registry Identifier: CTRP (Clinical Trials Reporting System))
CDR0000634077 (Registry Identifier: PDQ (Physician Data Query))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

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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Study Overview

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Detailed Description

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Enrollment (Actual)

Phase

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Accepts Healthy Volunteers

Genders Eligible for Study

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How is the study designed?

Design Details

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What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

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Collaborators and Investigators

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Collaborators

Study record dates

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Study Start

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimate)

Study Record Updates

Last Update Posted (Estimate)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

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