Phase III Study of High-Dose Gabapentin to Reduce Opioid Use for Mouth Pain During Chemoradiation in Head and Neck Cancer

What this Trial Is About

Researchers are evaluating whether high-dose gabapentin can reduce the need for opioid pain medications in patients experiencing mouth sores oral mucositis caused by chemotherapy and radiation treatment for squamous cell carcinoma of the head and neck. Oral mucositis can cause severe pain and complications such as difficulty swallowing, weight loss, feeding tube placement, interruptions in cancer treatment, hospitalizations, and decreased quality of life. Opioids are commonly used to treat this pain but come with significant side effects and risks of long-term use. In this phase III trial, patients are randomly assigned to receive either gabapentin or a placebo starting at radiation treatment day 8. The medication is given orally once daily on day 1, twice daily on day 2, and three times daily from day 3 onward. Both groups also receive standard chemotherapy, radiation, and pain management. Treatment continues until symptoms improve and other pain medications are stopped, followed by a gradual reduction in the study drug dose. Blood samples are collected throughout the study. After treatment, patients are followed for up to 6 months. Participants will have their need for opioids monitored during chemoradiation, along with the time to first opioid use and pain scores assessed up to 4 weeks after treatment ends. Researchers will also explore opioid use duration, symptom and quality of life changes, adverse events, medication tolerance, body weight, kidney function, immune cell counts, and feeding tube requirements. Study visits include regular assessments, blood tests, and questionnaires to gather detailed information on patient outcomes and safety.

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