This trial studies the how well extended-release microsphere capsule-based oxycodone (Xtampza ER) works in managing pain in participants with stage III-IV head and neck cancer receiving radiation therapy. Extended-release microsphere capsule-based oxycodone may provide long-acting relief during radiation therapy for head and neck cancer for patients who require a long-acting opioid medication.
Additional locations may be listed on ClinicalTrials.gov for NCT03317730.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVES:
I. Confirm the feasibility of utilizing microsphere oxycodone for analgesia during radiotherapy (RT) for locally advanced head and neck cancer (LAHNC) as part of a prospective clinical trial.
SECONDARY OBJECTIVES:
I. Assess pain control, quality of life, and drug related toxicity during RT and during short term follow-up.
OUTLINE:
Participants undergoing radiation therapy and requiring 2 or more daily doses of short acting opioids receive extended-release microsphere capsule-based oxycodone up to 3 months following the final fraction of radiation therapy in the absence of disease progression or unacceptable toxicity. Participants may receive taper of extended-release microsphere capsule-based oxycodone beginning 1 month following completion of radiation therapy.
At completion of the study, participants are followed up at 1 and 3 months.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationUniversity of Alabama at Birmingham Cancer Center
Principal InvestigatorAndrew Michael McDonald
