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

NCT ID: NCT03317730

Last Updated: 2021-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-01
• Study Completion Date: 2020-11-17

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Xtampza ER

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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

-

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Andrew McDonald

Assistant Professor - Department of Radiation Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hazelrig-Salter Radiation Oncology Center

Birmingham, Alabama, United States

Countries

United States

Other Identifiers

IRB-300000574

Identifier Type: -

Identifier Source: org_study_id