NCT03317730

Pilot Trial of Microsphere Oxycodone (Xtampza ER) for Pain Management in Patients Receiving Radiotherapy for Locally Advanced Head and Neck Cancer

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

To confirm the feasibility of studying Xtampza ER during radiotherapy (RT) for LAHNC as part of a prospective clinical trial.

Detailed description

To confirm the feasibility of studying Xtampza ER during radiotherapy (RT) for locally advanced head and neck cancer (LAHNC) as part of a prospective clinical trial. Investigators will also assess pain control, quality of life, and drug related toxicity during RT and during short term follow-up.

Conditions

• Locally Advanced Head and Neck Cancer

Interventions

Type	Name	Description
DRUG	Xtampza ER	Xtampza ER is a wax microsphere formulation of oxycodone that results in a nearly identical pharmacokinetic profile regardless of whether the capsule is intact when ingested or if ingested via enteral feeding tube as opposed to by mouth.

Timeline

• Start date: 2018-05-01
• Primary completion: 2019-12-04
• Completion: 2020-11-17
• First posted: 2017-10-23
• Last updated: 2021-07-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study