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

Stage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8 Clinical Trial

Official title:
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

Status Completed

Clinical Trial 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.

Clinical Trial Description

PRIMARY OBJECTIVES: I. To assess the pain-reduction effects of adding venlafaxine to a regimen of gabapentin and methadone to control pain during and after chemoradiation. SECONDARY OBJECTIVES: I. To assess the effect of venlafaxine hydrochloride (venlafaxine) of the rate of toxicities possibly or probably related to the pain control regimen. TERTIARY OBJECTIVES: I. The effect of venlafaxine on other quality of life scores, patient nutrition, hydration status, and opioid requirements during and after chemoradiotherapy (CRT). OUTLINE: Participants are randomized to 1 of 2 arms. ARM I: Participants receive gabapentin orally (PO) daily or 3 times a day (TID). Participants may also receive methadone PO TID and oxycodone PO every 8 hours as needed. Treatment continues for up to 12 months in the absence of disease progression or unacceptable toxicity. ARM II: Participants receive gabapentin, methadone, and oxycodone as in Arm I and venlafaxine PO twice daily (BID) or venlafaxine hydrochloride extended release daily for up to 12 months in the absence of disease progression or unacceptable toxicity. After completion of study treatment, participants are followed up at 4 weeks, 3, 6, 9, and 12 months, and then every 6 months for up to 24 months. ;

Study Design

Related Conditions & MeSH terms

Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Squamous Cell Carcinoma of Head and Neck
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

Clinical Trial Details

NCT number	NCT03574792
Study type	Interventional
Source	Roswell Park Cancer Institute
Contact
Status	Completed
Phase	N/A
Start date	May 3, 2018
Completion date	November 11, 2021

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.