NCT06992427 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 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Alliance for Clinical Trials in Oncology |
| Condition | Head and Neck Squamous Cell Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 228 participants |
| Start Date | 2025-06-05 |
| Primary Completion | 2029-08-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 228 participants in total. It began in 2025-06-05 with a primary completion date of 2029-08-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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: \-
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06992427 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Head and Neck Squamous Cell Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06992427 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 228 participants.
Is NCT06992427 currently recruiting?
Yes, NCT06992427 is actively recruiting participants. Contact the research team at cancercontrolprotocols@alliancenctn.org for enrollment information.
Where is the NCT06992427 trial being conducted?
This trial is being conducted at Gilbert, United States, Peoria, United States, Phoenix, United States, Phoenix, United States and 11 additional locations.
Who is sponsoring the NCT06992427 clinical trial?
NCT06992427 is sponsored by Alliance for Clinical Trials in Oncology. The trial plans to enroll 228 participants.