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

• Status: Completed
• Trial end date: 2020-11-17
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Alabama at Birmingham
• Treatments: Oxycodone

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:

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