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

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.

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

• 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

Eligibility basics and study details

Study type

Interventional

Phase

Phase 3

Ages

18 years and older

Sex

All

Healthy volunteers

Not accepted

Sponsor

Alliance for Clinical Trials in Oncology

Last updated on ClinicalTrials.gov

October 2, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites

+36 more sites listed on ClinicalTrials.gov