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High-dose Prophylactic Gabapentin (HOPE) vs. Placebo to Prevent Opioid Use for Oral Mucositis Pain During Concurrent Chemoradiation for Head and Neck Cancer
Sponsor: Alliance for Clinical Trials in Oncology
Summary
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
Official title: High-Dose Prophylactic Gabapentin (HOPE) to Prevent Opioid Use for Oral Mucositis Pain During Head and Neck Chemoradiotherapy: A Phase III Clinical Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
228
Start Date
2025-06-05
Completion Date
2031-04-15
Last Updated
2026-04-07
Healthy Volunteers
No
Conditions
Interventions
Gabapentin
Given PO
Placebo
Given PO
Chemotheraphy
Receive standard of care chemotherapy
Radiation Therapy
Undergo standard of care radiation
Analgesic Agent
Receive standard of care pain medication
Biospecimen Collection
Undergo blood sample collection
Survey Administration
Ancillary studies
Locations (187)
Arizona Center for Cancer Care - Gilbert
Gilbert, Arizona, United States
Arizona Center for Cancer Care-Peoria
Peoria, Arizona, United States
Arizona Center for Cancer Care - Biltmore
Phoenix, Arizona, United States
Arizona Center for Cancer Care - Phoenix
Phoenix, Arizona, United States
Arizona Center for Cancer Care - Osborn
Scottsdale, Arizona, United States
Arizona Center for Cancer Care - Scottsdale
Scottsdale, Arizona, United States
Arizona Center for Cancer Care-Surprise
Surprise, Arizona, United States
Arizona Center for Cancer Care
Tempe, Arizona, United States
AIS Cancer Center at San Joaquin Community Hospital
Bakersfield, California, United States
Kaiser Permanente Dublin
Dublin, California, United States
Kaiser Permanente-Fremont
Fremont, California, United States
Kaiser Permanente Fresno Orchard Plaza
Fresno, California, United States
Los Angeles General Medical Center
Los Angeles, California, United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States
Kaiser Permanente- Modesto MOB II
Modesto, California, United States
Kaiser Permanente-Modesto
Modesto, California, United States
Kaiser Permanente-Oakland
Oakland, California, United States
Kaiser Permanente-Roseville
Roseville, California, United States
Kaiser Permanente Downtown Commons
Sacramento, California, United States
Kaiser Permanente-South Sacramento
Sacramento, California, United States
Kaiser Permanente-San Francisco
San Francisco, California, United States
Kaiser Permanente-Santa Teresa-San Jose
San Jose, California, United States
Kaiser Permanente San Leandro
San Leandro, California, United States
Kaiser San Rafael-Gallinas
San Rafael, California, United States
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, United States
Kaiser Permanente-Santa Rosa
Santa Rosa, California, United States
Kaiser Permanente-South San Francisco
South San Francisco, California, United States
Kaiser Permanente-Vallejo
Vallejo, California, United States
Kaiser Permanente-Walnut Creek
Walnut Creek, California, United States
Saint Anthony Hospital
Lakewood, Colorado, United States
Kaiser Permanente Moanalua Medical Center
Honolulu, Hawaii, United States
Saint Luke's Cancer Institute - Boise
Boise, Idaho, United States
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho, United States
Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho, United States
Saint Luke's Cancer Institute - Meridian
Meridian, Idaho, United States
Saint Luke's Cancer Institute - Nampa
Nampa, Idaho, United States
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho, United States
Kootenai Clinic Cancer Services - Sandpoint
Sandpoint, Idaho, United States
Rush-Copley Medical Center
Aurora, Illinois, United States
Advocate Outpatient Center - Aurora
Aurora, Illinois, United States
Advocate Good Shepherd Hospital
Barrington, Illinois, United States
Illinois CancerCare-Bloomington
Bloomington, Illinois, United States
Illinois CancerCare-Canton
Canton, Illinois, United States
Illinois CancerCare-Carthage
Carthage, Illinois, United States
Advocate Illinois Masonic Medical Center
Chicago, Illinois, United States
AMG Crystal Lake - Oncology
Crystal Lake, Illinois, United States
Carle at The Riverfront
Danville, Illinois, United States
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, United States
Decatur Memorial Hospital
Decatur, Illinois, United States
Illinois CancerCare-Dixon
Dixon, Illinois, United States
Advocate Good Samaritan Hospital
Downers Grove, Illinois, United States
Carle Physician Group-Effingham
Effingham, Illinois, United States
Crossroads Cancer Center
Effingham, Illinois, United States
Advocate Sherman Hospital
Elgin, Illinois, United States
Illinois CancerCare-Eureka
Eureka, Illinois, United States
Illinois CancerCare-Galesburg
Galesburg, Illinois, United States
Advocate South Suburban Hospital
Hazel Crest, Illinois, United States
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, United States
AMG Libertyville - Oncology
Libertyville, Illinois, United States
Condell Memorial Hospital
Libertyville, Illinois, United States
Illinois CancerCare-Macomb
Macomb, Illinois, United States
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, United States
Trinity Medical Center
Moline, Illinois, United States
Carle BroMenn Medical Center
Normal, Illinois, United States
Carle Cancer Institute Normal
Normal, Illinois, United States
Cancer Care Center of O'Fallon
O'Fallon, Illinois, United States
HSHS Saint Elizabeth's Hospital
O'Fallon, Illinois, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, United States
Advocate Outpatient Center - Oak Lawn
Oak Lawn, Illinois, United States
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, United States
Advocate High Tech Medical Park
Palos Heights, Illinois, United States
Advocate Lutheran General Hospital
Park Ridge, Illinois, United States
Illinois CancerCare-Pekin
Pekin, Illinois, United States
Illinois CancerCare-Peoria
Peoria, Illinois, United States
Illinois CancerCare-Peru
Peru, Illinois, United States
Illinois CancerCare-Princeton
Princeton, Illinois, United States
Southern Illinois University School of Medicine
Springfield, Illinois, United States
Springfield Clinic
Springfield, Illinois, United States
Springfield Memorial Hospital
Springfield, Illinois, United States
Carle Cancer Center
Urbana, Illinois, United States
Illinois CancerCare - Washington
Washington, Illinois, United States
Mary Greeley Medical Center
Ames, Iowa, United States
McFarland Clinic - Ames
Ames, Iowa, United States
McFarland Clinic - Boone
Boone, Iowa, United States
Saint Luke's Hospital
Cedar Rapids, Iowa, United States
Mercy Hospital
Cedar Rapids, Iowa, United States
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa, United States
Methodist Jennie Edmundson Hospital
Council Bluffs, Iowa, United States
McFarland Clinic - Trinity Cancer Center
Fort Dodge, Iowa, United States
McFarland Clinic - Jefferson
Jefferson, Iowa, United States
McFarland Clinic - Marshalltown
Marshalltown, Iowa, United States
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, United States
Coborn Cancer Center at Saint Cloud Hospital
Saint Cloud, Minnesota, United States
Saint Francis Medical Center
Cape Girardeau, Missouri, United States
Freeman Health System
Joplin, Missouri, United States
Mercy Hospital South
St Louis, Missouri, United States
Mercy Hospital Saint Louis
St Louis, Missouri, United States
Community Hospital of Anaconda
Anaconda, Montana, United States
Billings Clinic Cancer Center
Billings, Montana, United States
Bozeman Health Deaconess Hospital
Bozeman, Montana, United States
Benefis Sletten Cancer Institute
Great Falls, Montana, United States
Logan Health Medical Center
Kalispell, Montana, United States
Community Medical Center
Missoula, Montana, United States
Nebraska Medicine-Bellevue
Bellevue, Nebraska, United States
CHI Health Good Samaritan
Kearney, Nebraska, United States
Nebraska Methodist Hospital
Omaha, Nebraska, United States
Nebraska Medicine-Village Pointe
Omaha, Nebraska, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Northwell Health Physicians Partners Radiation Medicine at Queens
Forest Hills, New York, United States
Northwell Health/Center for Advanced Medicine
Lake Success, New York, United States
Manhattan Eye Ear and Throat Hospital
New York, New York, United States
Lenox Hill Hospital
New York, New York, United States
Queens Cancer Center
Rego Park, New York, United States
Montefiore Medical Center-Einstein Campus
The Bronx, New York, United States
Montefiore Medical Center - Moses Campus
The Bronx, New York, United States
Sanford Bismarck Medical Center
Bismarck, North Dakota, United States
Sanford Broadway Medical Center
Fargo, North Dakota, United States
Sanford Roger Maris Cancer Center
Fargo, North Dakota, United States
Aultman Health Foundation
Canton, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Geisinger Cancer Center Dickson City
Dickson City, Pennsylvania, United States
UPMC Hillman Cancer Center Erie
Erie, Pennsylvania, United States
Saint Vincent Hospital
Erie, Pennsylvania, United States
UPMC Cancer Center at UPMC Horizon
Farrell, Pennsylvania, United States
UPMC Cancer Centers - Arnold Palmer Pavilion
Greensburg, Pennsylvania, United States
UPMC Pinnacle Cancer Center/Community Osteopathic Campus
Harrisburg, Pennsylvania, United States
Jefferson Hospital
Jefferson Hills, Pennsylvania, United States
Geisinger Medical Oncology-Lewisburg
Lewisburg, Pennsylvania, United States
UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
Mechanicsburg, Pennsylvania, United States
Forbes Hospital
Monroeville, Pennsylvania, United States
UPMC Cancer Center - Monroeville
Monroeville, Pennsylvania, United States
UPMC Hillman Cancer Center - Monroeville
Monroeville, Pennsylvania, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Jefferson Torresdale Hospital
Philadelphia, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, United States
UPMC-Shadyside Hospital
Pittsburgh, Pennsylvania, United States
UPMC-Saint Clair Hospital Cancer Center
Pittsburgh, Pennsylvania, United States
Geisinger Cancer Services-Pottsville
Pottsville, Pennsylvania, United States
UPMC Cancer Center at UPMC Northwest
Seneca, Pennsylvania, United States
Wexford Health and Wellness Pavilion
Wexford, Pennsylvania, United States
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, United States
Asplundh Cancer Pavilion
Willow Grove, Pennsylvania, United States
Gibbs Cancer Center-Pelham
Greer, South Carolina, United States
Spartanburg Medical Center
Spartanburg, South Carolina, United States
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota, United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, United States
Farmington Health Center
Farmington, Utah, United States
University of Utah Sugarhouse Health Center
Salt Lake City, Utah, United States
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States
South Jordan Health Center
South Jordan, Utah, United States
United Hospital Center
Bridgeport, West Virginia, United States
WVUH-Berkely Medical Center
Martinsburg, West Virginia, United States
West Virginia University Healthcare
Morgantown, West Virginia, United States
Camden Clark Medical Center
Parkersburg, West Virginia, United States
Princeton Community Hospital
Princeton, West Virginia, United States
Wheeling Hospital/Schiffler Cancer Center
Wheeling, West Virginia, United States
Langlade Hospital and Cancer Center
Antigo, Wisconsin, United States
Aurora Cancer Care-Southern Lakes VLCC
Burlington, Wisconsin, United States
Aurora Saint Luke's South Shore
Cudahy, Wisconsin, United States
Aurora Health Care Germantown Health Center
Germantown, Wisconsin, United States
Aurora Cancer Care-Grafton
Grafton, Wisconsin, United States
Aurora BayCare Medical Center
Green Bay, Wisconsin, United States
Aurora Cancer Care-Kenosha South
Kenosha, Wisconsin, United States
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States
Aurora Bay Area Medical Group-Marinette
Marinette, Wisconsin, United States
Aspirus Medford Hospital
Medford, Wisconsin, United States
Froedtert Menomonee Falls Hospital
Menomonee Falls, Wisconsin, United States
Aurora Cancer Care-Milwaukee
Milwaukee, Wisconsin, United States
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Aurora Sinai Medical Center
Milwaukee, Wisconsin, United States
Drexel Town Square Health Center
Oak Creek, Wisconsin, United States
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin, United States
Aurora Cancer Care-Racine
Racine, Wisconsin, United States
Aspirus Cancer Care - James Beck Cancer Center
Rhinelander, Wisconsin, United States
Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan, Wisconsin, United States
Aspirus Cancer Care - Stevens Point
Stevens Point, Wisconsin, United States
Aurora Medical Center in Summit
Summit, Wisconsin, United States
Vince Lombardi Cancer Clinic-Two Rivers
Two Rivers, Wisconsin, United States
Aspirus Regional Cancer Center
Wausau, Wisconsin, United States
Aurora Cancer Care-Milwaukee West
Wauwatosa, Wisconsin, United States
Aurora West Allis Medical Center
West Allis, Wisconsin, United States
Froedtert West Bend Hospital/Kraemer Cancer Center
West Bend, Wisconsin, United States
Aspirus Cancer Care - Wisconsin Rapids
Wisconsin Rapids, Wisconsin, United States