Home › Head and Neck Squamous Cell Carcinoma › NCT06992427
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:
\-
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
- Gabapentin (drug)
- Placebo (drug)
- Chemotheraphy (drug)
- Radiation Therapy (radiation)
- Analgesic Agent (drug)
- Biospecimen Collection (procedure)
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.
| Arizona | Arizona 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 |
| California | AIS Cancer Center at San Joaquin Community Hospital, Bakersfield Los Angeles General Medical Center, Los Angeles USC / Norris Comprehensive Cancer Center, Los Angeles |
| Colorado | Kaiser Permanente-Franklin, Denver Kaiser Permanente-Rock Creek, Lafayette Saint Anthony Hospital, Lakewood |
| Idaho | Saint 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 |
| Illinois | Advocate 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 |
| Iowa | Mary 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 |
| Maine | Harold 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 |
| Minnesota | Sanford Joe Lueken Cancer Center, Bemidji Coborn Cancer Center at Saint Cloud Hospital, Saint Cloud |
| Missouri | Saint Francis Medical Center, Cape Girardeau Freeman Health System, Joplin Mercy Hospital Saint Louis, St Louis Mercy Hospital South, St Louis |
| Montana | Community 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 |
| Nebraska | Nebraska Medicine-Bellevue, Bellevue Nebraska Medicine-Village Pointe, Omaha Nebraska Methodist Hospital, Omaha University of Nebraska Medical Center, Omaha |
| New Jersey | Jefferson Cherry Hill Hospital, Cherry Hill Sidney Kimmel Cancer Center Washington Township, Sewell |
| New York | Roswell 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 Dakota | Sanford Bismarck Medical Center, Bismarck Sanford Broadway Medical Center, Fargo Sanford Roger Maris Cancer Center, Fargo |
| Ohio | Aultman Health Foundation, Canton |
| Oklahoma | University of Oklahoma Health Sciences Center, Oklahoma City |
| Pennsylvania | Geisinger 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 Carolina | Gibbs Cancer Center-Pelham, Greer Spartanburg Medical Center, Spartanburg |
| South Dakota | Sanford Cancer Center Oncology Clinic, Sioux Falls Sanford USD Medical Center - Sioux Falls, Sioux Falls |
| Utah | Farmington 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 Virginia | United 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 |
| Wisconsin | Langlade 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.