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

Conditions

• 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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Gabapentin — DRUG
  Given PO
• Placebo — DRUG
  Given PO
• Chemotheraphy — DRUG
  Receive standard of care chemotherapy
• Radiation Therapy — RADIATION
  Undergo standard of care radiation
• Analgesic Agent — DRUG
  Receive standard of care pain medication
• Biospecimen Collection — PROCEDURE
  Undergo blood sample collection
• Survey Administration — OTHER
  Ancillary studies

Study Details

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

Key Dates

Start date

Jun 5, 2025

Status verified

May 2026

Primary completion

Aug 15, 2029

Completion

Apr 15, 2031

Study Design

Enrollment

228 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Arms

• Placebo Comparator: Arm I (Placebo)
  Starting by radiation treatment 8, patients receive placebo PO QD on day 1, BID on day 2, then TID starting day 3 onward. Patients also receive standard of care radiation, chemotherapy and pain medications. Treatment with placebo continues in the absence of disease progression or unacceptable toxicity, until the symptoms of oral mucositis and other treatment effects begin to resolve and other pain medications has been stopped. Patients then continue to receive placebo TID for 9 additional days, at sequentially smaller doses, then BID for 1 day and QD for one day before stopping. Patients undergo blood sample collection throughout the study.
• Experimental: Arm II (Gabapentin)
  Starting by radiation treatment 8, patients receive gabapentin PO QD on day 1, BID on day 2, then TID starting day 3 onward. Patients also receive standard of care radiation, chemotherapy and pain medications. Treatment with gabapentin continues in the absence of disease progression or unacceptable toxicity, until the symptoms of oral mucositis and other treatment effects begin to resolve and other pain medications has been stopped. Patients then continue to receive gabapentin TID for 9 additional days, at sequentially smaller doses, then BID for 1 day and QD for one day before stopping. Patients undergo blood sample collection throughout the study.

Primary Outcome Measure

Need to use opioids during chemoradiation therapy (CRT) [ Time Frame: Up to 7 weeks ]

Central Contacts

• Nancy Garcia
  773-702-9171
  [email protected]

Locations (200)

Find similar trials in Gilbert, AZ

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