Major Program
NCI Community Oncology Research Program
Research Group
Community Oncology and Prevention Trials
Sponsor
Alliance for Clinical Trials in Oncology
Status
Recruiting
NCT ID
NCT06992427
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
Intervention
Analgesic Agent, Biospecimen Collection, Chemotheraphy, Gabapentin, Placebo, Radiation Therapy, Survey Administration
Condition
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
Investigators
John M. Schallenkamp, Site Public Contact, Deborah W. Wilbur