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

Launched by ALLIANCE FOR CLINICAL TRIALS IN ONCOLOGY · May 19, 2025

Keywords

ClinConnect Summary

This clinical trial, called the HOPE trial, is studying whether a medication called gabapentin can help reduce pain from mouth sores (known as oral mucositis) in patients receiving chemotherapy and radiation for head and neck cancer. Oral mucositis is a common side effect of these treatments and can be very painful, making it hard to swallow and eat, which might lead to more serious health issues. The goal of the trial is to see if gabapentin can lessen the need for stronger pain medications, like opioids, which can have unwanted side effects.

To participate in this trial, patients must be 18 years or older and have a confirmed diagnosis of squamous cell carcinoma of the head and neck. They should not have had any previous treatments for their cancer and must be planning to receive specific chemotherapy and radiation treatments. Participants will take gabapentin or a placebo (a pill with no active ingredients) and will be monitored for their pain levels and overall health during their treatment. It's important to note that certain health conditions and medications may exclude someone from joining the trial, so eligibility will be carefully reviewed.

Gender

ALL

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:
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