CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 62 enrolled
Drug / intervention
Gabapentin +6 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/NCT03574792
NCT03574792Phase 2Completed

A Randomized, Open-Label Study to Assess the Pain, Toxicity, and Quality of Life Effects of Adding Venlafaxine to the Pain Management Regimen for Patients Treated With Chemoradiation for Head and Neck Cancer

Roswell Park Cancer Institute·interventional·Posted Jul 2, 2018·Updated Apr 16, 2026

In Brief

A Phase 2 clinical trial evaluating Gabapentin, Methadone, and 5 other interventions for Stage III Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8 and Stage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8. Completed, enrolled 62 participants across 1 site.

Detailed Summary

This trial studies how well gabapentin, methadone, and oxycodone with or without venlafaxine hydrochloride work in managing pain in participants with stage II-IV squamous cell head and neck cancer undergoing chemoradiation therapy. Gabapentin may reduce the need for these pain medications if given at the start of radiation therapy. Methadone and oxycodone may help relieve pain caused by cancer. Venlafaxine hydrochloride may prevent or improve pain caused by cancer. It is now yet known whether giving gabapentin, methadone, and oxycodone with venlafaxine hydrochloride will work better in managing pain in participants with squamous cell head and neck cancer undergoing chemoradiation therapy.

Study Details

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

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedJul 2, 2018
Enrollment StartMay 3, 2018
Primary CompletionApr 19, 2021
Study CompletionNov 11, 2021
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 8 years ago

Interventions

Gabapentindrug

Given PO

Methadonedrug

Given PO

Oxycodonedrug

Given PO

Quality-of-Life Assessmentother

Ancillary studies

Questionnaire Administrationother

Ancillary studies

Venlafaxinedrug

Given PO

Venlafaxine Hydrochloride Extended Releasedrug

Given PO