Phase 3Recruiting

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

High-Dose Prophylactic Gabapentin (HOPE) to Prevent Opioid Use for Oral Mucositis Pain During Head and Neck Chemoradiotherapy: A Phase III Clinical Trial

Sponsor
Alliance for Clinical Trials in Oncology (Academic or other)
Enrolment
228 planned
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
Interventions
Gabapentin; Placebo; Chemotheraphy; Radiation Therapy; Analgesic Agent; Biospecimen Collection; Survey Administration
Ages
adults, older adults
Registry
NCT06992427

From the registry

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

Primary outcomes

  • Need to use opioids during chemoradiation therapy (CRT)
Full record on ClinicalTrials.gov