RecruitingHead and Neck Squamous Cell CarcinomaStage I Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8Stage II Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8

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

Eligible age

18+ yrs

Accepts

All genders

Locations

23 states

Healthy volunteers

See if you qualify for this study

Answer a few quick questions about your location and health. Takes about a minute.

Check my eligibility →

About this study

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

Sponsor: Alliance for Clinical Trials in Oncology

You may qualify if…

✓ Histologic documentation of disease: Squamous cell carcinoma of the head and neck region.
✓ \* Stage: I-IV
✓ No prior treatment for head and neck cancer
✓ Planned treatment with cisplatin-based chemoradiation therapy (weekly or once every 3 weeks \[q 3 week\])
✓ Able to swallow capsules whole
✓ No known hypersensitivity to gabapentin or its ingredients
✓ No patients on dialysis or with transplanted organs
✓ 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. Concurrent cancer therapy for other cancers is not allowed