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

Alliance for Clinical Trials in Oncology
NCT IDNCT06992427ClinicalTrials.gov data as of Apr 2026
Phase

Phase 3

Target enrollment

228

Study length

about 5.9 years

Ages

18+

Locations

187 sites in AZ, CA, CO +18

What this study is about

This trial is testing 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

Simplified from trial records by PatientMatch.

What you may be asked to do

  • 1.Receive Radiation Therapy
  • 2.Survey Administration
  • 3.Take Analgesic Agent
  • +3 more

Participation Burden

What's physically and logistically required of participants.

Logistics & Travel
In-person visits

Requires travel to a study site

Physical Intervention
Oral

How treatment is administered

Treatment Assignment
Randomized & Blinded

You may get a placebo/standard care, and you won't know which.

Extracted study details

Pulled from the trial record to show what is being tested and what the study is measuring.

Drug classes

gabapentin (Modulates calcium channels; used for neuropathic pain and seizures)

Drug routes

oral (Oral Tablet)

Endpoints

Secondary: Patient-reported pain scores

Procedures

diagnostic, radiation

Body systems

Oncology