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RECRUITING Phase 3 ClinicalTrials.gov

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 • ClinicalTrials.gov ID: NCT06992427

Registry updated: 2026-10-02
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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 region

Interventions

  • Gabapentin (Drug)
    Given PO
  • Placebo (Drug)
    Given PO
  • Chemotheraphy (Drug)
    Receive standard of care chemotherapy
  • Radiation Therapy (Radiation)
    Undergo standard of care radiation
  • Analgesic Agent (Drug)
    Receive standard of care pain medication
  • Biospecimen Collection (Procedure)
    Undergo blood sample collection
  • Survey Administration (Other)
    Ancillary studies

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: \-

Conditions

Head and Neck Squamous Cell Carcinoma Stage I Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8 Stage II Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8 Stage III Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8 Stage IV Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8

Locations

  • 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
  • Mayo Clinic Hospital in Arizona — 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
  • University of Arkansas for Medical Sciences — Little Rock, Arkansas, 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
  • UCHealth Memorial Hospital Central — Colorado Springs, Colorado, United States
  • Memorial Hospital North — Colorado Springs, Colorado, United States
  • Kaiser Permanente-Franklin — Denver, Colorado, United States
  • Kaiser Permanente-Rock Creek — Lafayette, Colorado, United States
  • CommonSpirit Saint Anthony Hospital Cancer Center — Lakewood, Colorado, United States
  • Kaiser Permanente-Lone Tree — Lone Tree, 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
  • Harold Alfond Center for Cancer Care — Augusta, Maine, United States
  • MaineHealth Coastal Cancer Treatment Center — Bath, Maine, United States
  • MaineHealth Cancer Care and IV Therapy - Brunswick — Brunswick, Maine, United States
  • MaineHealth LincolnHealth Hospital — Damariscotta, Maine, United States
  • MaineHealth Maine Medical Center - Portland — Portland, Maine, United States
  • MaineHealth Cancer Care Center of York County — Sanford, Maine, United States
  • MaineHealth Maine Medical Center- Scarborough — Scarborough, Maine, United States
  • MaineHealth Cancer Care and IV Therapy - South Portland — South Portland, Maine, United States
  • Mayo Clinic Health System in Albert Lea — Albert Lea, Minnesota, United States
  • Sanford Joe Lueken Cancer Center — Bemidji, Minnesota, United States
  • Mayo Clinic Health Systems-Mankato — Mankato, Minnesota, United States
  • Mayo Clinic in Rochester — Rochester, 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
  • Jefferson Cherry Hill Hospital — Cherry Hill, New Jersey, United States
  • Sidney Kimmel Cancer Center Washington Township — Sewell, New Jersey, 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
  • Stony Brook University Medical Center — Stony Brook, 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
  • Ohio State University Comprehensive Cancer Center — Columbus, 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
  • UPMC Hillman Cancer Center — 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
  • Aspirus Cancer Care-Antigo-Volm 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
  • Mayo Clinic Health System-Eau Claire Clinic — Eau Claire, 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
  • Mayo Clinic Health System-Franciscan Healthcare — 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-Rhinelander-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 Cancer Care-Wausau — 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
  • Memorial Hospital of Laramie County — Cheyenne, Wyoming, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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