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Gabapentin for the Reduction of Radiation Therapy Induced Pain During the Treatment of Oropharyngeal Cancer

NCT03269344 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2022-01-26

Study results available
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Summary

Strategies to minimize and mitigate external beam radiation therapy related mucositis and pain during the treatment of head and neck cancer remain limited. The investigators hypothesize that gabapentin could be used to delay or reduce treatment-related pain, reliance on opioid medication, and improve the quality of life for these patients.

Conditions

  • Oropharynx Cancer

Interventions

DRUG

Gabapentin

Gabapentin is an anticonvulsant and has been used to manage neuropathic pain and is FDA-approved for the treatment of post-herpetic neuralgia and partial onset seizures

DRUG

Placebo Oral Capsule

Placebo

Sponsors & Collaborators

  • Henry Ford Health System

    lead OTHER

Principal Investigators

  • Farzan Siddiqui, MD PhD · Henry Ford Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-06-05
Primary Completion
2020-12-09
Completion
2020-12-09
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT03269344 on ClinicalTrials.gov