Gabapentin, Methadone, and Oxycodone With or Without Venlafaxine Hydrochloride in Managing Pain in Participants With Stage II-IV Squamous Cell Head and Neck Cancer Undergoing Chemoradiation Therapy
NCT03574792 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 62
Last updated 2026-04-16
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.
Conditions
- Stage III Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8
- Stage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8
Interventions
- DRUG
-
Gabapentin
Given PO
- DRUG
-
Methadone
Given PO
- DRUG
-
Oxycodone
Given PO
- OTHER
-
Quality-of-Life Assessment
Ancillary studies
- OTHER
-
Questionnaire Administration
Ancillary studies
- DRUG
-
Venlafaxine
Given PO
- DRUG
-
Venlafaxine Hydrochloride Extended Release
Given PO
Sponsors & Collaborators
-
Roswell Park Cancer Institute
lead OTHER
Principal Investigators
-
Anurag Singh · Roswell Park Cancer Institute
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-05-03
- Primary Completion
- 2021-04-19
- Completion
- 2021-11-11
- FDA Drug
- Yes
Countries
- United States
Study Locations
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