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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

NCT06992427 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 228

Last updated 2026-05-11

No results posted yet for this study

Summary

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

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

Interventions

DRUG

Gabapentin

Given PO

DRUG

Placebo

Given PO

DRUG

Chemotheraphy

Receive standard of care chemotherapy

RADIATION

Radiation Therapy

Undergo standard of care radiation

DRUG

Analgesic Agent

Receive standard of care pain medication

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

OTHER

Survey Administration

Ancillary studies

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-05
Primary Completion
2029-08-15
Completion
2031-04-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06992427 on ClinicalTrials.gov