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OncoMatch/Clinical Trials/NCT06992427

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

Is NCT06992427 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Gabapentin and Chemotheraphy for head and neck squamous cell carcinoma.

Phase 3RecruitingAlliance for Clinical Trials in OncologyNCT06992427Data as of May 2026

Treatment: Gabapentin · Chemotheraphy · Analgesic AgentThis 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

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Extracted eligibility criteria

Cancer type

Head and Neck Squamous Cell Carcinoma

Disease stage

Required: Stage I, II, III, IV

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: surgery

Exception: history of surgery and radioactive iodine for the treatment of thyroid cancer are eligible

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.

Cannot have received: radiation therapy

Exception: history of surgery and radioactive iodine for the treatment of thyroid cancer are eligible

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.

Cannot have received: chemotherapy

No prior treatment for head and neck cancer

Cannot have received: investigational agent

No investigational agent within 30 days prior to registration

Lab requirements

Kidney function

creatinine ≤ 1.5 x upper limit of normal (uln)

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Arizona Center for Cancer Care - Gilbert · Gilbert, Arizona
  • Arizona Center for Cancer Care-Peoria · Peoria, Arizona
  • Arizona Center for Cancer Care - Biltmore · Phoenix, Arizona
  • Arizona Center for Cancer Care - Phoenix · Phoenix, Arizona
  • Arizona Center for Cancer Care - Osborn · Scottsdale, Arizona

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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