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Study identifier: NCT06992427 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

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  ·  Sponsor: Alliance for Clinical Trials in Oncology

PhasePhase 3
Planned participants228
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

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

This description comes directly from the study's public registry record.

Talk to the study team

Nancy Garcia  ·  773-702-9171  ·  cancercontrolprotocols@alliancenctn.org

Always discuss trial participation with your own doctor first.

Locations (200)

Arizona Center for Cancer Care - GilbertGilbert, Arizona, United StatesRecruiting
Arizona Center for Cancer Care-PeoriaPeoria, Arizona, United StatesRecruiting
Arizona Center for Cancer Care - BiltmorePhoenix, Arizona, United StatesRecruiting
Arizona Center for Cancer Care - PhoenixPhoenix, Arizona, United StatesRecruiting
Arizona Center for Cancer Care - OsbornScottsdale, Arizona, United StatesRecruiting
Arizona Center for Cancer Care - ScottsdaleScottsdale, Arizona, United StatesRecruiting
Arizona Center for Cancer Care-SurpriseSurprise, Arizona, United StatesRecruiting
Arizona Center for Cancer CareTempe, Arizona, United StatesRecruiting
AIS Cancer Center at San Joaquin Community HospitalBakersfield, California, United StatesRecruiting
Kaiser Permanente DublinDublin, California, United StatesActive Not Recruiting
Kaiser Permanente-FremontFremont, California, United StatesActive Not Recruiting
Kaiser Permanente Fresno Orchard PlazaFresno, California, United StatesActive Not Recruiting

+ 188 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT06992427