This randomized phase I/II pilot 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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02531906.
PRIMARY OBJECTIVES:
I. Collect preliminary data on the safety and efficacy of two analgesic regimens that can be used to design larger studies for comparing such regimens.
SECONDARY OBJECTIVES:
I. Examine effects of the treatment regimens on pain control, oral mucositis, and quality-of-life ratings scores during and after chemoradiation therapy (CRT).
TERTIARY OBJECTIVES:
I. To assess treatment regimen effect on patient nutrition and hydration status during and after CRT (weight loss, vitals, oral [PO] tolerance, etc.).
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive gabapentin PO once daily (QD) and increasing to thrice daily (TID) as tolerated for up to 7 weeks during radiotherapy.
ARM II: Patients receive gabapentin PO QD and increasing to TID as tolerated, methadone hydrochloride PO twice daily (BID), and oxycodone hydrochloride PO every 8 hours (Q8H) as needed (PRN) for up to 7 weeks during radiotherapy.
All patients may continue to receive treatment for pain throughout their course of chemoradiation therapy (and up to 24 months following CRT if continuing on a pain regimen).
After completion of study, patients are followed up at 30 days, and at 3, 6, 9, and 12 months. Patients requiring prolonged analgesic therapy may be followed up every 6 months for 24 months.
Trial PhasePhase I/II
Trial Typesupportive care
Lead OrganizationRoswell Park Cancer Institute
Principal InvestigatorAnurag K. Singh
