Gabapentin, Methadone Hydrochloride, and Oxycodone Hydrochloride in Improving Quality of Life in Patients With Stage II-IV Head and Neck Cancer During Chemoradiation

• Status: Completed
• Trial end date: 2018-06-14
• Target enrollment: 0
• Participant gender: All

Summary

This randomized pilot clinical trial studies the side effects of gabapentin and how well it works when given together with methadone hydrochloride and oxycodone hydrochloride in improving quality of life in patients with stage II-IV head and neck cancer during chemoradiation. Gabapentin, methadone hydrochloride, and oxycodone hydrochloride may help relieve moderate or severe pain caused by head and neck cancer during and after chemoradiation therapy.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Roswell Park Cancer Institute
• Collaborator: National Cancer Institute (NCI)
• Treatments: Gabapentin; gamma-Aminobutyric Acid; Methadone; Oxycodone

Criteria

Inclusion Criteria:

• Patients who are eligible for chemoradiation therapy of the head and neck

• Baseline creatinine (Cr) no greater than 1.5 times the upper limit of normal

• Have a clinical stage II-IV head and neck carcinoma

• Have a pathologic diagnosis of squamous cell carcinoma of the head and neck region

• Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2

• Ability to swallow and retain oral medication or take through a feeding tube

• Patients of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately

• Patient or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

Exclusion Criteria:

• Patients who have previously been treated with surgery or radiation for head and neck cancer and/or are being treated for recurrent head and neck cancer

• Patients with known brain metastases will be excluded from this clinical trial

• Any patients prescribed medications for chronic pain and/or neuropathy will be excluded, including patients under treatment of a pain specialist or substance-abuse programs

• Uncontrolled concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

• Pregnant or nursing female patients

• Unwilling or unable to follow protocol requirements

• Any condition which in the Investigator's opinion deems the patient an unsuitable candidate to receive study drug

• Received an investigational agent within 30 days prior to enrollment

• Patients on medications that prolong QT interval

• Patients on dialysis or with transplanted organs

• Patients already enrolled on other studies of systemic pain control agents