NCT06992427|RecruitingPhase 3DMCFDA Drug

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

HOPE

High-Dose Prophylactic Gabapentin (HOPE) to Prevent Opioid Use for Oral Mucositis Pain During Head and Neck Chemoradiotherapy: A Phase III Clinical Trial

Alliance for Clinical Trials in Oncology ClinicalTrials.gov

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2 other identifiers

A222301NCI-2025-00501

Study Type

interventional

Target

228

Locations

1 country

Sites

154

Timeline

RegisteredMay 2025

StartedJun 2025

CompletionApr 2031

Brief 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

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

228

participants targeted

Target at P25-P50 for phase_3

Timeline

60mo left

Started Jun 2025

Longer than P75 for phase_3

Geographic Reach

1 country

154 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

5.9 years study duration

Study Progress16%

Jun 2025Apr 2031

First Submitted

Initial submission to the registry

April 28, 2025

Completed

1 month until next milestone

First Posted

Study publicly available on registry

May 28, 2025

Completed

8 days until next milestone

Study Start

First participant enrolled

June 5, 2025

Completed

4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2029

Expected

1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2031

Last Updated

March 4, 2026

Status Verified

March 1, 2026

Enrollment Period

4.2 years

First QC Date

April 28, 2025

Last Update Submit

March 2, 2026

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

Outcome Measures

Primary Outcomes (1)

Need to use opioids during chemoradiation therapy (CRT)
Will be tested using a two-sample test of proportions. Will report the proportion of patients not using opioids within the 7 weeks of CRT in the two arms and the 95% confidence interval (CI) of the difference in the proportions.
Up to 7 weeks

Secondary Outcomes (2)

Time to first opioid use
Up to 9 weeks
Patient-reported pain scores
Through 4 weeks post CRT (up to 14 weeks)

Other Outcomes (16)

Need to use opioids during CRT by sex
Up to 7 weeks
Need to use opioids during CRT by race
Up to 7 weeks
Need to use opioids during CRT by ethnicity
Up to 7 weeks
+13 more other outcomes

Study Arms (2)

Arm I (Placebo)

PLACEBO COMPARATOR

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.

Drug: PlaceboDrug: ChemotheraphyRadiation: Radiation TherapyDrug: Analgesic AgentProcedure: Biospecimen CollectionOther: Survey Administration

Arm II (Gabapentin)

EXPERIMENTAL

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.

Drug: GabapentinDrug: ChemotheraphyRadiation: Radiation TherapyDrug: Analgesic AgentProcedure: Biospecimen CollectionOther: Survey Administration

Interventions

GabapentinDRUG

Given PO

Also known as: Gralise, Neurontin

Arm II (Gabapentin)

PlaceboDRUG

Given PO

Arm I (Placebo)

ChemotheraphyDRUG

Receive standard of care chemotherapy