Pilot Trial of Microsphere Oxycodone (Xtampza ER) for Pain Management in Patients Receiving Radiotherapy for Locally Advanced Head and Neck Cancer (RAD 1702)

The University of Alabama at Birmingham

Status and phase: Completed; Early Phase 1

Conditions: Locally Advanced Head and Neck Cancer

Treatments: Drug: Xtampza ER

Study type: Interventional

Funder types: Other

Identifiers

NCT03317730

IRB-300000574

Details and patient eligibility

About

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

Full 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.

Enrollment: 28 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

28 participants in 1 patient group

RT + Xtampza ER

Experimental group

Description:

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.

Treatment:

Drug: Xtampza ER