Taking people in United StatesPhase 3

Gabapentin to prevent opioid use for mouth sore pain in head and neck cancer

Tests gabapentin against placebo for mouth-sore pain in adults with head and neck cancer.

Plain-language title generated from the registry record
Registry title: High-dose Prophylactic Gabapentin (HOPE) vs. Placebo to Prevent Opioid Use for Oral Mucositis Pain During Concurrent Chemoradiation for Head and Neck Cancer

Key facts

Where: Albert Lea, Ames, Anaconda, Antigo, Augusta, Aurora, Bakersfield, Barrington, Bath, Bellevue, Bemidji, Billings, Bismarck, Bloomington, Boise, Boone, Bozeman, Bridgeport, Brunswick, Buffalo, Burlington, Canton, Cape Girardeau, Carthage, Cedar Rapids, Cherry Hill, Cheyenne, Chicago, Clive, Coeur d'Alene, Colorado Springs, Columbus, Council Bluffs, Crystal Lake, Cudahy, Damariscotta, Danville, Decatur, Denver, Des Moines, Dickson City, Dixon, Downers Grove, Dublin, Eau Claire, Effingham, Elgin, Erie, Eureka, Fargo, Farmington, Farrell, Forest Hills, Fort Dodge, Fremont, Fresno, Fruitland, Galesburg, Germantown, Gilbert, Grafton, Great Falls, Green Bay, Greensburg, Greer, Harrisburg, Hazel Crest, Honolulu, Jefferson, Jefferson Hills, Joplin, Kalispell, Kearney, Kenosha, Kewanee, La Crosse, Lafayette, Lake Success, Lakewood, Lewisburg, Libertyville, Little Rock, Lone Tree, Los Angeles, Macomb, Mankato, Marinette, Marshalltown, Martinsburg, Mattoon, Mechanicsburg, Medford, Menomonee Falls, Meridian, Milwaukee, Missoula, Modesto, Moline, Monroeville, Morgantown, Mount Vernon, Nampa, New York, Newport News, Normal, O'Fallon, Oak Creek, Oak Lawn, Oakland, Oklahoma City, Omaha, Oshkosh, Ottawa, Palos Heights, Park Ridge, Parkersburg, Pekin, Peoria, Peru, Philadelphia, Phoenix, Pittsburgh, Portland, Post Falls, Pottsville, Princeton, Racine, Rego Park, Rhinelander, Rochester, Roseville, Sacramento, Saint Cloud, Salt Lake City, San Francisco, San Jose, San Leandro, San Rafael, Sandpoint, Sanford, Santa Clara, Santa Rosa, Scarborough, Scottsdale, Seneca, Sewell, Sheboygan, Sioux Falls, South Jordan, South Portland, South San Francisco, Spartanburg, Springfield, St Louis, Stevens Point, Stony Brook, Summit, Surprise, Tempe, The Bronx, Two Rivers, Urbana, Vallejo, Walnut Creek, Washington, Wausau, Wauwatosa, West Allis, West Bend, Wexford, Wheeling, Wilkes-Barre, Willow Grove, and Wisconsin Rapids, United StatesSee the 216 sites
Phase: Phase 3

Where in United States

Mayo Clinic Health System in Albert LeaAlbert Lea, United StatesTaking people
Mary Greeley Medical CenterAmes, United StatesTaking people
McFarland Clinic - AmesAmes, United StatesTaking people
Community Hospital of AnacondaAnaconda, United StatesTaking people
Aspirus Cancer Care-Antigo-Volm Cancer CenterAntigo, United StatesTaking people
Harold Alfond Center for Cancer CareAugusta, United StatesTaking people
Advocate Outpatient Center - AuroraAurora, United StatesTaking people
Rush-Copley Medical CenterAurora, United StatesNo longer taking part
AIS Cancer Center at San Joaquin Community HospitalBakersfield, United StatesTaking people
Advocate Good Shepherd HospitalBarrington, United StatesTaking people
MaineHealth Coastal Cancer Treatment CenterBath, United StatesTaking people
Nebraska Medicine-BellevueBellevue, United StatesTaking people
Sanford Joe Lueken Cancer CenterBemidji, United StatesTaking people
Billings Clinic Cancer CenterBillings, United StatesTaking people
Sanford Bismarck Medical CenterBismarck, United StatesTaking people
Illinois CancerCare-BloomingtonBloomington, United StatesTaking people
Saint Luke's Cancer Institute - BoiseBoise, United StatesTaking people
McFarland Clinic - BooneBoone, United StatesNo longer taking part
Bozeman Health Deaconess HospitalBozeman, United StatesTaking people
United Hospital CenterBridgeport, United StatesTaking people
MaineHealth Cancer Care and IV Therapy - BrunswickBrunswick, United StatesTaking people
Roswell Park Cancer InstituteBuffalo, United StatesTaking people
Aurora Cancer Care-Southern Lakes VLCCBurlington, United StatesTaking people
Aultman Health FoundationCanton, United StatesTaking people
Illinois CancerCare-CantonCanton, United StatesTaking people
Saint Francis Medical CenterCape Girardeau, United StatesTaking people
Illinois CancerCare-CarthageCarthage, United StatesTaking people
Mercy HospitalCedar Rapids, United StatesTaking people
Oncology Associates at Mercy Medical CenterCedar Rapids, United StatesTaking people
Saint Luke's HospitalCedar Rapids, United StatesTaking people
Jefferson Cherry Hill HospitalCherry Hill, United StatesTaking people
Memorial Hospital of Laramie CountyCheyenne, United StatesTaking people
Advocate Illinois Masonic Medical CenterChicago, United StatesTaking people
Mercy Cancer Center-West LakesClive, United StatesTaking people
Kootenai Health - Coeur d'AleneCoeur d'Alene, United StatesTaking people
Memorial Hospital NorthColorado Springs, United StatesTaking people
UCHealth Memorial Hospital CentralColorado Springs, United StatesTaking people
Ohio State University Comprehensive Cancer CenterColumbus, United StatesTaking people
Methodist Jennie Edmundson HospitalCouncil Bluffs, United StatesNo longer taking part
AMG Crystal Lake - OncologyCrystal Lake, United StatesTaking people
Aurora Saint Luke's South ShoreCudahy, United StatesTaking people
MaineHealth LincolnHealth HospitalDamariscotta, United StatesTaking people
Carle at The RiverfrontDanville, United StatesTaking people
Geisinger Medical CenterDanville, United StatesTaking people
Cancer Care Specialists of Illinois - DecaturDecatur, United StatesTaking people
Decatur Memorial HospitalDecatur, United StatesTaking people
Kaiser Permanente-FranklinDenver, United StatesTaking people
Mercy Medical Center - Des MoinesDes Moines, United StatesTaking people
Geisinger Cancer Center Dickson CityDickson City, United StatesTaking people
Illinois CancerCare-DixonDixon, United StatesTaking people
Advocate Good Samaritan HospitalDowners Grove, United StatesTaking people
Kaiser Permanente DublinDublin, United StatesNo longer taking part
Mayo Clinic Health System-Eau Claire ClinicEau Claire, United StatesTaking people
Carle Physician Group-EffinghamEffingham, United StatesTaking people
Crossroads Cancer CenterEffingham, United StatesTaking people
Advocate Sherman HospitalElgin, United StatesTaking people
Saint Vincent HospitalErie, United StatesTaking people
UPMC Hillman Cancer Center ErieErie, United StatesTaking people
Illinois CancerCare-EurekaEureka, United StatesTaking people
Sanford Broadway Medical CenterFargo, United StatesTaking people
Sanford Roger Maris Cancer CenterFargo, United StatesTaking people
Farmington Health CenterFarmington, United StatesTaking people
UPMC Cancer Center at UPMC HorizonFarrell, United StatesTaking people
Northwell Health Physicians Partners Radiation Medicine at QueensForest Hills, United StatesTaking people
McFarland Clinic - Trinity Cancer CenterFort Dodge, United StatesTaking people
Kaiser Permanente-FremontFremont, United StatesNo longer taking part
Kaiser Permanente Fresno Orchard PlazaFresno, United StatesNo longer taking part
Saint Luke's Cancer Institute - FruitlandFruitland, United StatesTaking people
Illinois CancerCare-GalesburgGalesburg, United StatesTaking people
Aurora Health Care Germantown Health CenterGermantown, United StatesTaking people
Arizona Center for Cancer Care - GilbertGilbert, United StatesTaking people
Aurora Cancer Care-GraftonGrafton, United StatesTaking people
Benefis Sletten Cancer InstituteGreat Falls, United StatesTaking people
Aurora BayCare Medical CenterGreen Bay, United StatesTaking people
UPMC Cancer Centers - Arnold Palmer PavilionGreensburg, United StatesTaking people
Gibbs Cancer Center-PelhamGreer, United StatesTaking people
UPMC Pinnacle Cancer Center/Community Osteopathic CampusHarrisburg, United StatesTaking people
Advocate South Suburban HospitalHazel Crest, United StatesTaking people
Kaiser Permanente Moanalua Medical CenterHonolulu, United StatesNo longer taking part
McFarland Clinic - JeffersonJefferson, United StatesNo longer taking part
Jefferson HospitalJefferson Hills, United StatesTaking people
Freeman Health SystemJoplin, United StatesTaking people
Logan Health Medical CenterKalispell, United StatesTaking people
CHI Health Good SamaritanKearney, United StatesNo longer taking part
Aurora Cancer Care-Kenosha SouthKenosha, United StatesTaking people
Illinois CancerCare-Kewanee ClinicKewanee, United StatesTaking people
Gundersen Lutheran Medical CenterLa Crosse, United StatesTaking people
Mayo Clinic Health System-Franciscan HealthcareLa Crosse, United StatesTaking people
Kaiser Permanente-Rock CreekLafayette, United StatesTaking people
Northwell Health/Center for Advanced MedicineLake Success, United StatesTaking people
CommonSpirit Saint Anthony Hospital Cancer CenterLakewood, United StatesTaking people
Geisinger Medical Oncology-LewisburgLewisburg, United StatesTaking people
AMG Libertyville - OncologyLibertyville, United StatesTaking people
Condell Memorial HospitalLibertyville, United StatesTaking people
University of Arkansas for Medical SciencesLittle Rock, United StatesTaking people
Kaiser Permanente-Lone TreeLone Tree, United StatesTaking people
Los Angeles General Medical CenterLos Angeles, United StatesTaking people
USC / Norris Comprehensive Cancer CenterLos Angeles, United StatesTaking people
Illinois CancerCare-MacombMacomb, United StatesTaking people
Mayo Clinic Health Systems-MankatoMankato, United StatesTaking people
Aurora Bay Area Medical Group-MarinetteMarinette, United StatesTaking people
McFarland Clinic - MarshalltownMarshalltown, United StatesTaking people
WVUH-Berkely Medical CenterMartinsburg, United StatesTaking people
Carle Physician Group-Mattoon/CharlestonMattoon, United StatesTaking people
UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer PavilionMechanicsburg, United StatesTaking people
Aspirus Medford HospitalMedford, United StatesTaking people
Froedtert Menomonee Falls HospitalMenomonee Falls, United StatesTaking people
Saint Luke's Cancer Institute - MeridianMeridian, United StatesTaking people
Aurora Cancer Care-MilwaukeeMilwaukee, United StatesTaking people
Aurora Saint Luke's Medical CenterMilwaukee, United StatesTaking people
Aurora Sinai Medical CenterMilwaukee, United StatesTaking people
Medical College of WisconsinMilwaukee, United StatesTaking people
Community Medical CenterMissoula, United StatesTaking people
Kaiser Permanente- Modesto MOB IIModesto, United StatesNo longer taking part
Kaiser Permanente-ModestoModesto, United StatesNo longer taking part
Trinity Medical CenterMoline, United StatesTaking people
Forbes HospitalMonroeville, United StatesTaking people
UPMC Cancer Center - MonroevilleMonroeville, United StatesTaking people
UPMC Hillman Cancer Center - MonroevilleMonroeville, United StatesTaking people
West Virginia University HealthcareMorgantown, United StatesTaking people
SSM Health Good SamaritanMount Vernon, United StatesTaking people
Saint Luke's Cancer Institute - NampaNampa, United StatesTaking people
Lenox Hill HospitalNew York, United StatesTaking people
Manhattan Eye Ear and Throat HospitalNew York, United StatesTaking people
Peninsula Cancer Institute-Newport NewsNewport News, United StatesTaking people
Carle BroMenn Medical CenterNormal, United StatesTaking people
Carle Cancer Institute NormalNormal, United StatesTaking people
Cancer Care Center of O'FallonO'Fallon, United StatesTaking people
HSHS Saint Elizabeth's HospitalO'Fallon, United StatesTaking people
Drexel Town Square Health CenterOak Creek, United StatesTaking people
Advocate Christ Medical CenterOak Lawn, United StatesTaking people
Advocate Outpatient Center - Oak LawnOak Lawn, United StatesTaking people
Kaiser Permanente-OaklandOakland, United StatesNo longer taking part
University of Oklahoma Health Sciences CenterOklahoma City, United StatesTaking people
Nebraska Medicine-Village PointeOmaha, United StatesTaking people
University of Nebraska Medical CenterOmaha, United StatesTaking people
Nebraska Methodist HospitalOmaha, United StatesNo longer taking part
Vince Lombardi Cancer Clinic - OshkoshOshkosh, United StatesTaking people
Illinois CancerCare-Ottawa ClinicOttawa, United StatesTaking people
Advocate High Tech Medical ParkPalos Heights, United StatesTaking people
Advocate Lutheran General HospitalPark Ridge, United StatesTaking people
Camden Clark Medical CenterParkersburg, United StatesTaking people
Illinois CancerCare-PekinPekin, United StatesTaking people
Arizona Center for Cancer Care-PeoriaPeoria, United StatesTaking people
Illinois CancerCare-PeoriaPeoria, United StatesTaking people
Illinois CancerCare-PeruPeru, United StatesTaking people
Jefferson Torresdale HospitalPhiladelphia, United StatesTaking people
Thomas Jefferson University HospitalPhiladelphia, United StatesTaking people
Arizona Center for Cancer Care - BiltmorePhoenix, United StatesTaking people
Arizona Center for Cancer Care - PhoenixPhoenix, United StatesTaking people
Mayo Clinic Hospital in ArizonaPhoenix, United StatesTaking people
Allegheny General HospitalPittsburgh, United StatesTaking people
UPMC Hillman Cancer CenterPittsburgh, United StatesTaking people
UPMC-Saint Clair Hospital Cancer CenterPittsburgh, United StatesTaking people
UPMC-Shadyside HospitalPittsburgh, United StatesTaking people
MaineHealth Maine Medical Center - PortlandPortland, United StatesTaking people
Kootenai Clinic Cancer Services - Post FallsPost Falls, United StatesTaking people
Geisinger Cancer Services-PottsvillePottsville, United StatesTaking people
Illinois CancerCare-PrincetonPrinceton, United StatesTaking people
Princeton Community HospitalPrinceton, United StatesTaking people
Aurora Cancer Care-RacineRacine, United StatesTaking people
Queens Cancer CenterRego Park, United StatesTaking people
Aspirus Cancer Care-Rhinelander-James Beck Cancer CenterRhinelander, United StatesTaking people
Mayo Clinic in RochesterRochester, United StatesTaking people
Kaiser Permanente-RosevilleRoseville, United StatesNo longer taking part
Kaiser Permanente Downtown CommonsSacramento, United StatesNo longer taking part
Kaiser Permanente-South SacramentoSacramento, United StatesNo longer taking part
Coborn Cancer Center at Saint Cloud HospitalSaint Cloud, United StatesTaking people
Huntsman Cancer Institute/University of UtahSalt Lake City, United StatesTaking people
University of Utah Sugarhouse Health CenterSalt Lake City, United StatesTaking people
Kaiser Permanente-San FranciscoSan Francisco, United StatesNo longer taking part
Kaiser Permanente-Santa Teresa-San JoseSan Jose, United StatesNo longer taking part
Kaiser Permanente San LeandroSan Leandro, United StatesNo longer taking part
Kaiser San Rafael-GallinasSan Rafael, United StatesNo longer taking part
Kootenai Clinic Cancer Services - SandpointSandpoint, United StatesTaking people
MaineHealth Cancer Care Center of York CountySanford, United StatesTaking people
Kaiser Permanente Medical Center - Santa ClaraSanta Clara, United StatesNo longer taking part
Kaiser Permanente-Santa RosaSanta Rosa, United StatesNo longer taking part
MaineHealth Maine Medical Center- ScarboroughScarborough, United StatesTaking people
Arizona Center for Cancer Care - OsbornScottsdale, United StatesTaking people
Arizona Center for Cancer Care - ScottsdaleScottsdale, United StatesTaking people
UPMC Cancer Center at UPMC NorthwestSeneca, United StatesTaking people
Sidney Kimmel Cancer Center Washington TownshipSewell, United StatesTaking people
Vince Lombardi Cancer Clinic-SheboyganSheboygan, United StatesTaking people
Sanford Cancer Center Oncology ClinicSioux Falls, United StatesTaking people
Sanford USD Medical Center - Sioux FallsSioux Falls, United StatesTaking people
South Jordan Health CenterSouth Jordan, United StatesTaking people
MaineHealth Cancer Care and IV Therapy - South PortlandSouth Portland, United StatesTaking people
Kaiser Permanente-South San FranciscoSouth San Francisco, United StatesNo longer taking part
Spartanburg Medical CenterSpartanburg, United StatesTaking people
Southern Illinois University School of MedicineSpringfield, United StatesTaking people
Springfield ClinicSpringfield, United StatesTaking people
Springfield Memorial HospitalSpringfield, United StatesTaking people
Mercy Hospital Saint LouisSt Louis, United StatesTaking people
Mercy Hospital SouthSt Louis, United StatesTaking people
Aspirus Cancer Care - Stevens PointStevens Point, United StatesTaking people
Stony Brook University Medical CenterStony Brook, United StatesTaking people
Aurora Medical Center in SummitSummit, United StatesTaking people
Arizona Center for Cancer Care-SurpriseSurprise, United StatesTaking people
Arizona Center for Cancer CareTempe, United StatesTaking people
Montefiore Medical Center - Moses CampusThe Bronx, United StatesTaking people
Montefiore Medical Center-Einstein CampusThe Bronx, United StatesTaking people
Vince Lombardi Cancer Clinic-Two RiversTwo Rivers, United StatesTaking people
Carle Cancer CenterUrbana, United StatesTaking people
Kaiser Permanente-VallejoVallejo, United StatesNo longer taking part
Kaiser Permanente-Walnut CreekWalnut Creek, United StatesNo longer taking part
Illinois CancerCare - WashingtonWashington, United StatesTaking people
Aspirus Cancer Care-WausauWausau, United StatesTaking people
Aurora Cancer Care-Milwaukee WestWauwatosa, United StatesTaking people
Aurora West Allis Medical CenterWest Allis, United StatesTaking people
Froedtert West Bend Hospital/Kraemer Cancer CenterWest Bend, United StatesTaking people
Wexford Health and Wellness PavilionWexford, United StatesTaking people
Wheeling Hospital/Schiffler Cancer CenterWheeling, United StatesTaking people
Geisinger Wyoming Valley/Henry Cancer CenterWilkes-Barre, United StatesTaking people
Asplundh Cancer PavilionWillow Grove, United StatesTaking people
Aspirus Cancer Care - Wisconsin RapidsWisconsin Rapids, United StatesTaking people

Questions to ask the study team

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Trial details

Who runs it: Alliance for Clinical Trials in Oncology
Trial code: NCT06992427
Record updated: 4 November 2026
Original description: 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 regionRead full original descriptionShow less
High-Dose Prophylactic Gabapentin (HOPE) to Prevent Opioid Use for Oral Mucositis Pain During Head and Neck Chemoradiotherapy: A Phase III Clinical Trial
This phase III trial tests if gabapentin can prevent the need for opiate pain medication for mouth sores (oral mucositis) in patients undergoing treatment with chemotherapy and radiation for squamous cell carcinoma of the head and neck region. Oral mucositis is a common side effect of radiation treatment and can cause severe pain, dysphagia, and weight loss resulting in feeding tube placement, worse health-related quality of life, treatment interruptions, unplanned hospitalizations, and significant financial burden. Mucositis pain is often treated with opioid pain medications which do provide pain relief but have many known side effects not limited to mental clouding, constipation, fatigue, endocrinopathy, neurotoxicity, sleep-disordered breathing, and most distressingly persistent opioid use. Gabapentin may help relieve pain from oral mucositis caused by radiation while also reducing the need for opiate pain medications for patients receiving chemotherapy and radiation for squamous cell carcinoma of the head and neck region
Inclusion: 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: -.
ClinicalTrials.gov NCT06992427