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Gabapentin to Prevent Opioid Use for Mouth Sores During Head and Neck Cancer Treatment

This study is testing if a medication called gabapentin can help prevent the need for opioid pain medications when you're getting chemotherapy and radiation for head and neck cancer. These treatments can cause painful mouth sores (oral mucositis), which often require strong pain relievers like opioids. While opioids help with pain, they can also cause side effects like constipation and fatigue. This study aims to see if gabapentin can reduce or eliminate the need for opioids. You might be able to join if you have squamous cell carcinoma of the head and neck, haven't had prior treatment for it, and are planning to receive cisplatin-based chemoradiation. The study will be considered successful if more patients receiving gabapentin don't need opioids during their treatment. The current recruitment status is unclear.

Study design
This interventional study plans to enroll 228 participants. It compares gabapentin to a placebo (an inactive substance) to see which is better at preventing opioid use.
What's involved
You would receive either gabapentin or a placebo by mouth, along with standard chemotherapy, radiation, and pain medication. The primary endpoint is measured for up to 7 weeks.
Compensation
Not stated in the trial record.
Follow-up
The study will explore the duration of opioid use at 3 months, 6 months, and 1 year after initiation.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06992427

High-dose Prophylactic Gabapentin (HOPE) vs. Placebo to Prevent Opioid Use for Oral Mucositis Pain During Concurrent Chemoradiation for Head and Neck Cancer

Recruiting
PHASE3Ages 18+InterventionalSupportive care
Alliance for Clinical Trials in Oncology
~228 participants
Updated 2026-05-11 on ClinicalTrials.gov
What's tested:GabapentinPlaceboChemotheraphyRadiation TherapyAnalgesic AgentBiospecimen Collection

At a glance

Recruiting sites
169 of 200 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Need to use opioids during chemoradiation therapy (CRT)
Measured over Up to 7 weeks

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

Explore related trials

Head and Neck Squamous Cell Carcinoma

Where it's being run

200 sites across 23 states
Illinois43
Wisconsin28
Pennsylvania24
California21
Iowa10
New York9
Arizona8
Maine8

Who to contact

Nancy Garcia
[email protected]
773-702-9171
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

What this trial measures

  • Need to use opioids during chemoradiation therapy (CRT)Up to 7 weeks

    Will be tested using a two-sample test of proportions. Will report the proportion of patients not using opioids within the 7 weeks of CRT in the two arms and the 95% confidence interval (CI) of the difference in the proportions.