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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

NCT ID: NCT06992427
Registry status: Recruiting
Study type: Interventional
Phase: Phase 3
Sponsor: Alliance for Clinical Trials in Oncology
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

Overview

ClinicalTrials.gov lists this study as Recruiting.

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

Enrollment: 228 participants (Estimated).

What is being studied

Intervention: Acetaminophen
Intervention: Acetanilides
Intervention: Acids, Acyclic
Intervention: Acids, Carbocyclic
Intervention: Amides
Intervention: Amines
Intervention: Amino Acids
Intervention: Amino Acids, Peptides, and Proteins
Intervention: Aminobutyrates
Drug: Analgesic Agent
Intervention: Anilides
Intervention: Aniline Compounds
Procedure: Biospecimen Collection
Intervention: Butyrates
Intervention: Carboxylic Acids
Drug: Chemotheraphy
Intervention: Cyclohexanecarboxylic Acids
Intervention: Cyclohexanes
Intervention: Cycloparaffins
Drug: Gabapentin
Intervention: Gabapentin
Intervention: gamma-Aminobutyric Acid
Intervention: Hydrocarbons
Intervention: Hydrocarbons, Alicyclic
Intervention: Hydrocarbons, Cyclic
Intervention: Organic Chemicals
Drug: Placebo
Radiation: Radiation Therapy
Intervention: Radiotherapy
Other: Survey Administration
Intervention: Therapeutics

Who may be eligible

Ages: 18 Years to no maximum
Sex: All
Healthy volunteers accepted: No

ClinicalTrials.gov lists the following 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: \-

Study locations

212 study locations are listed.

Recruiting site status is explicitly provided for 212 locations; 187 are listed as Recruiting.

Countries: United States

Arizona, United States: 9
Arkansas, United States: 1
California, United States: 21
Colorado, United States: 6
Hawaii, United States: 1
Idaho, United States: 7
Illinois, United States: 43
Iowa, United States: 10
Maine, United States: 8
Minnesota, United States: 5
Missouri, United States: 4
Montana, United States: 6
Nebraska, United States: 5
New Jersey, United States: 2
New York, United States: 9
North Dakota, United States: 3
Ohio, United States: 2
Oklahoma, United States: 1
Pennsylvania, United States: 24
South Carolina, United States: 2
South Dakota, United States: 2
Utah, United States: 4
West Virginia, United States: 6
Wisconsin, United States: 30
Wyoming, United States: 1

Sample of listed locations

Arizona Center for Cancer Care - Gilbert — Gilbert, Arizona, 85297, United States — Recruiting
Arizona Center for Cancer Care-Peoria — Peoria, Arizona, 85381, United States — Recruiting
Arizona Center for Cancer Care - Biltmore — Phoenix, Arizona, 85016, United States — Recruiting
Arizona Center for Cancer Care - Phoenix — Phoenix, Arizona, 85027, United States — Recruiting
Mayo Clinic Hospital in Arizona — Phoenix, Arizona, 85054, United States — Recruiting
Arizona Center for Cancer Care - Osborn — Scottsdale, Arizona, 85251, United States — Recruiting
Arizona Center for Cancer Care - Scottsdale — Scottsdale, Arizona, 85258, United States — Recruiting
Arizona Center for Cancer Care-Surprise — Surprise, Arizona, 85374, United States — Recruiting
Arizona Center for Cancer Care — Tempe, Arizona, 85284, United States — Recruiting
University of Arkansas for Medical Sciences — Little Rock, Arkansas, 72205, United States — Recruiting
AIS Cancer Center at San Joaquin Community Hospital — Bakersfield, California, 93301, United States — Recruiting
Los Angeles General Medical Center — Los Angeles, California, 90033, United States — Recruiting
USC / Norris Comprehensive Cancer Center — Los Angeles, California, 90033, United States — Recruiting
Memorial Hospital North — Colorado Springs, Colorado, 80920, United States — Recruiting
UCHealth Memorial Hospital Central — Colorado Springs, Colorado, 80909, United States — Recruiting
Kaiser Permanente-Franklin — Denver, Colorado, 80205, United States — Recruiting
Kaiser Permanente-Rock Creek — Lafayette, Colorado, 80026, United States — Recruiting
CommonSpirit Saint Anthony Hospital Cancer Center — Lakewood, Colorado, 80228, United States — Recruiting
Kaiser Permanente-Lone Tree — Lone Tree, Colorado, 80124, United States — Recruiting
Saint Luke's Cancer Institute - Boise — Boise, Idaho, 83712, United States — Recruiting
Kootenai Health - Coeur d'Alene — Coeur d'Alene, Idaho, 83814, United States — Recruiting
Saint Luke's Cancer Institute - Fruitland — Fruitland, Idaho, 83619, United States — Recruiting
Saint Luke's Cancer Institute - Meridian — Meridian, Idaho, 83642, United States — Recruiting
Saint Luke's Cancer Institute - Nampa — Nampa, Idaho, 83687, United States — Recruiting
Kootenai Clinic Cancer Services - Post Falls — Post Falls, Idaho, 83854, United States — Recruiting

Study details

Start date: June 5, 2025
Primary completion date: August 15, 2029
Completion date: April 15, 2031
First posted: May 28, 2025
Collaborators: National Cancer Institute (NCI)

Source and update information

Source: ClinicalTrials.gov
NCT ID: NCT06992427
Registry last updated: October 2, 2026
QualifiedStudies registry data refreshed: October 5, 2026
QualifiedStudies record fetched: October 5, 2026

View NCT06992427 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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