CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 65 enrolled
Drug / intervention
Gabapentin +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03269344
NCT03269344Phase 3Completed
CompareCT.gov

Randomized Phase III, Double-Blind, Placebo Controlled Study of Prophylactic Gabapentin for the Reduction of Radiation Therapy Induced Pain During the Treatment of Oropharyngeal Squamous Cell Carcinoma

Henry Ford Health System·interventional·Posted Aug 31, 2017·Updated Jan 26, 2022

In Brief

A Phase 3 clinical trial evaluating Gabapentin and Placebo Oral Capsule for Oropharynx Cancer. Completed, enrolled 65 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOropharynx Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedAug 31, 2017
Enrollment StartJun 5, 2017
Primary CompletionDec 9, 2020
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 8.8 years ago

Interventions

Gabapentindrug

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

Placebo Oral Capsuledrug

Placebo