This phase II trial studies how well best supportive care with or without gabapentin works in treating patients with human papillomavirus (HPV)-related oropharyngeal cancer that has spread from its original site of growth to nearby tissues or lymph nodes who are receiving radiation therapy with or without chemotherapy. Subjects receiving radiation and chemotherapy for head and neck cancer often develop pain in the mouth and throat. These symptoms are usually managed with best supportive care including opioid pain medication and other pain relievers. Gabapentin may reduce the need for these pain medications if given at the start of radiation therapy.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03423264.
PRIMARY OBJECTIVES:
I. To compare rates of opioid requirement as a function of supportive care in patients experiencing Common Terminology Criteria for Adverse Events (CTCAE) grade >= 2 oral mucositis at completion of radiation or chemoradiation.
SECONDARY OBJECTIVES:
I. To compare total opioid equivalent dose above baseline opioid requirement at end of radiation, quality of life metrics, swallowing function, feeding-tube dependence, and protocol compliance in patients managed with best supportive care with or without prophylactic gabapentin.
II. To investigate rates of gabapentin-related toxicity and discontinuation for patients treated on protocol.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive best supportive care.
ARM II: Patients receive best supportive care as in Arm I. Patients also receive gabapentin orally (PO) once daily (QD) on day 1 of radiation therapy (RT), twice daily (BID) on days 2-4 of RT, and 3 times daily (TID) starting on day 5 of RT and continues until 6 weeks after completion of radiation or chemoradiation therapy.
After completion of study, patients are followed up at 6 weeks, 3, 6, 12, and 24 months post radiation therapy.
Trial PhasePhase II
Trial Typesupportive care
Lead OrganizationUniversity of Chicago Comprehensive Cancer Center
Principal InvestigatorDaniel J. Haraf
