UAB - Center for Clinical and Translational Science

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

Purpose

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

Condition

Locally Advanced Head and Neck Cancer

Eligibility

Eligible Ages: Over 19 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

Inclusion Criteria

Histologically confirmed locally advanced cancer of mucosa of the head and neck. - Eligible subsites will include nasal cavity, paranasal sinuses, nasopharynx, oropharynx, oral cavity, major salivary glands, oropharynx, larynx, hypopharynx, cervical esophagus, or unknown primary site with lymph node metastases. - Clinical or pathologic stage III-IV - Scheduled to receive RT with curative intent with the expectation that some portion of the mucosa of the upper aerodigestive tract will receive a dose of at least 50 Gray. - Eastern Cooperative Oncology Group (ECOG) performance status 0-2. - Age > 19 years - Subjects given written informed consent

Exclusion Criteria

Study Design

Phase: Early Phase 1
Study Type: Interventional
Allocation: N/A
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental RT + Xtampza ER	This study will enroll patients scheduled to receive radiation therapy (RT), but RT details are not specified by this protocol. Patients taking long acting opioid analgesics prior to enrollment will be converted to an equivalent dose of Xtampza ER at the time of enrollment. For the remaining patients not previously prescribed opioid analgesics, Xtampza ER will be initiated when 2 or more daily doses of short acting opioids are required, resulting in a total daily dose of at least 30mg morphine sulfate equivalent. During RT, pain will be assessed on a weekly basis using the PI-NRS and the dose of Xtampza ER will be adjusted at the discretion of the treating physician, with recommendation to maintain an equivalent of 100% daily opioid requirement. Assessment for tapering of Xtampza ER will begin 1 month following the completion of RT at the time of first follow-up.The study period will end 3 months following the final fraction of RT.	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.

More Details

Status: Completed
Sponsor: University of Alabama at Birmingham

Study Contact

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.