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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

RecruitingPhase 3

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

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
Inclusion Criteria:

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

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

Exclusion Criteria:

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About the study

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

What is being tested

Sponsor: Alliance for Clinical Trials in Oncology · Participants: 228 · Started: Jun 5, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06992427

Locations in the U.S.

ArizonaArizona Center for Cancer Care - Gilbert, Gilbert
Arizona Center for Cancer Care-Peoria, Peoria
Arizona Center for Cancer Care - Biltmore, Phoenix
Arizona Center for Cancer Care - Phoenix, Phoenix
Arizona Center for Cancer Care - Osborn, Scottsdale
Arizona Center for Cancer Care - Scottsdale, Scottsdale
Arizona Center for Cancer Care-Surprise, Surprise
Arizona Center for Cancer Care, Tempe
CaliforniaAIS Cancer Center at San Joaquin Community Hospital, Bakersfield
Los Angeles General Medical Center, Los Angeles
USC / Norris Comprehensive Cancer Center, Los Angeles
ColoradoKaiser Permanente-Franklin, Denver
Kaiser Permanente-Rock Creek, Lafayette
Saint Anthony Hospital, Lakewood
IdahoSaint Luke's Cancer Institute - Boise, Boise
Kootenai Health - Coeur d'Alene, Coeur d'Alene
Saint Luke's Cancer Institute - Fruitland, Fruitland
Saint Luke's Cancer Institute - Meridian, Meridian
Saint Luke's Cancer Institute - Nampa, Nampa
Kootenai Clinic Cancer Services - Post Falls, Post Falls
Kootenai Clinic Cancer Services - Sandpoint, Sandpoint
IllinoisAdvocate Outpatient Center - Aurora, Aurora
Advocate Good Shepherd Hospital, Barrington
Illinois CancerCare-Bloomington, Bloomington
Illinois CancerCare-Canton, Canton
Illinois CancerCare-Carthage, Carthage
Advocate Illinois Masonic Medical Center, Chicago
AMG Crystal Lake - Oncology, Crystal Lake
Cancer Care Specialists of Illinois - Decatur, Decatur
Decatur Memorial Hospital, Decatur
Illinois CancerCare-Dixon, Dixon
Advocate Good Samaritan Hospital, Downers Grove
Crossroads Cancer Center, Effingham
Advocate Sherman Hospital, Elgin
Illinois CancerCare-Eureka, Eureka
Illinois CancerCare-Galesburg, Galesburg
Advocate South Suburban Hospital, Hazel Crest
Illinois CancerCare-Kewanee Clinic, Kewanee
AMG Libertyville - Oncology, Libertyville
Condell Memorial Hospital, Libertyville
Illinois CancerCare-Macomb, Macomb
Cancer Care Center of O'Fallon, O'Fallon
HSHS Saint Elizabeth's Hospital, O'Fallon
Advocate Christ Medical Center, Oak Lawn
Advocate Outpatient Center - Oak Lawn, Oak Lawn
Illinois CancerCare-Ottawa Clinic, Ottawa
Advocate High Tech Medical Park, Palos Heights
Advocate Lutheran General Hospital, Park Ridge
Illinois CancerCare-Pekin, Pekin
Illinois CancerCare-Peoria, Peoria
Illinois CancerCare-Peru, Peru
Illinois CancerCare-Princeton, Princeton
Southern Illinois University School of Medicine, Springfield
Springfield Clinic, Springfield
Springfield Memorial Hospital, Springfield
Illinois CancerCare - Washington, Washington
IowaMary Greeley Medical Center, Ames
McFarland Clinic - Ames, Ames
Mercy Hospital, Cedar Rapids
Oncology Associates at Mercy Medical Center, Cedar Rapids
Saint Luke's Hospital, Cedar Rapids
McFarland Clinic - Trinity Cancer Center, Fort Dodge
McFarland Clinic - Marshalltown, Marshalltown
MaineHarold Alfond Center for Cancer Care, Augusta
MaineHealth Coastal Cancer Treatment Center, Bath
MaineHealth Cancer Care and IV Therapy - Brunswick, Brunswick
MaineHealth LincolnHealth Hospital, Damariscotta
MaineHealth Maine Medical Center - Portland, Portland
MaineHealth Cancer Care Center of York County, Sanford
MaineHealth Maine Medical Center- Scarborough, Scarborough
MaineHealth Cancer Care and IV Therapy - South Portland, South Portland
MinnesotaSanford Joe Lueken Cancer Center, Bemidji
Coborn Cancer Center at Saint Cloud Hospital, Saint Cloud
MissouriSaint Francis Medical Center, Cape Girardeau
Freeman Health System, Joplin
Mercy Hospital Saint Louis, St Louis
Mercy Hospital South, St Louis
MontanaCommunity Hospital of Anaconda, Anaconda
Billings Clinic Cancer Center, Billings
Bozeman Health Deaconess Hospital, Bozeman
Benefis Sletten Cancer Institute, Great Falls
Logan Health Medical Center, Kalispell
Community Medical Center, Missoula
NebraskaNebraska Medicine-Bellevue, Bellevue
Nebraska Medicine-Village Pointe, Omaha
Nebraska Methodist Hospital, Omaha
University of Nebraska Medical Center, Omaha
New JerseyJefferson Cherry Hill Hospital, Cherry Hill
Sidney Kimmel Cancer Center Washington Township, Sewell
New YorkRoswell Park Cancer Institute, Buffalo
Northwell Health Physicians Partners Radiation Medicine at Queens, Forest Hills
Northwell Health/Center for Advanced Medicine, Lake Success
Lenox Hill Hospital, New York
Manhattan Eye Ear and Throat Hospital, New York
Queens Cancer Center, Rego Park
Stony Brook University Medical Center, Stony Brook
Montefiore Medical Center - Moses Campus, The Bronx
Montefiore Medical Center-Einstein Campus, The Bronx
North DakotaSanford Bismarck Medical Center, Bismarck
Sanford Broadway Medical Center, Fargo
Sanford Roger Maris Cancer Center, Fargo
OhioAultman Health Foundation, Canton
OklahomaUniversity of Oklahoma Health Sciences Center, Oklahoma City
PennsylvaniaGeisinger Medical Center, Danville
Geisinger Cancer Center Dickson City, Dickson City
Saint Vincent Hospital, Erie
UPMC Hillman Cancer Center Erie, Erie
UPMC Cancer Center at UPMC Horizon, Farrell
UPMC Cancer Centers - Arnold Palmer Pavilion, Greensburg
UPMC Pinnacle Cancer Center/Community Osteopathic Campus, Harrisburg
Jefferson Hospital, Jefferson Hills
Geisinger Medical Oncology-Lewisburg, Lewisburg
UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion, Mechanicsburg
Forbes Hospital, Monroeville
UPMC Cancer Center - Monroeville, Monroeville
UPMC Hillman Cancer Center - Monroeville, Monroeville
Jefferson Torresdale Hospital, Philadelphia
Thomas Jefferson University Hospital, Philadelphia
Allegheny General Hospital, Pittsburgh
UPMC-Saint Clair Hospital Cancer Center, Pittsburgh
UPMC-Shadyside Hospital, Pittsburgh
University of Pittsburgh Cancer Institute (UPCI), Pittsburgh
Geisinger Cancer Services-Pottsville, Pottsville
UPMC Cancer Center at UPMC Northwest, Seneca
Wexford Health and Wellness Pavilion, Wexford
Geisinger Wyoming Valley/Henry Cancer Center, Wilkes-Barre
Asplundh Cancer Pavilion, Willow Grove
South CarolinaGibbs Cancer Center-Pelham, Greer
Spartanburg Medical Center, Spartanburg
South DakotaSanford Cancer Center Oncology Clinic, Sioux Falls
Sanford USD Medical Center - Sioux Falls, Sioux Falls
UtahFarmington Health Center, Farmington
Huntsman Cancer Institute/University of Utah, Salt Lake City
University of Utah Sugarhouse Health Center, Salt Lake City
South Jordan Health Center, South Jordan
West VirginiaUnited Hospital Center, Bridgeport
WVUH-Berkely Medical Center, Martinsburg
West Virginia University Healthcare, Morgantown
Camden Clark Medical Center, Parkersburg
Princeton Community Hospital, Princeton
Wheeling Hospital/Schiffler Cancer Center, Wheeling
WisconsinLanglade Hospital and Cancer Center, Antigo
Aurora Cancer Care-Southern Lakes VLCC, Burlington
Aurora Saint Luke's South Shore, Cudahy
Aurora Health Care Germantown Health Center, Germantown
Aurora Cancer Care-Grafton, Grafton
Aurora BayCare Medical Center, Green Bay
Aurora Cancer Care-Kenosha South, Kenosha
Gundersen Lutheran Medical Center, La Crosse
Aurora Bay Area Medical Group-Marinette, Marinette
Aspirus Medford Hospital, Medford
Froedtert Menomonee Falls Hospital, Menomonee Falls
Aurora Cancer Care-Milwaukee, Milwaukee
Aurora Saint Luke's Medical Center, Milwaukee
Aurora Sinai Medical Center, Milwaukee
Medical College of Wisconsin, Milwaukee
Drexel Town Square Health Center, Oak Creek
Vince Lombardi Cancer Clinic - Oshkosh, Oshkosh
Aurora Cancer Care-Racine, Racine
Aspirus Cancer Care - James Beck Cancer Center, Rhinelander
Vince Lombardi Cancer Clinic-Sheboygan, Sheboygan
Aspirus Cancer Care - Stevens Point, Stevens Point
Aurora Medical Center in Summit, Summit
Vince Lombardi Cancer Clinic-Two Rivers, Two Rivers
Aspirus Regional Cancer Center, Wausau
Aurora Cancer Care-Milwaukee West, Wauwatosa
Aurora West Allis Medical Center, West Allis
Froedtert West Bend Hospital/Kraemer Cancer Center, West Bend
Aspirus Cancer Care - Wisconsin Rapids, Wisconsin Rapids

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.