Status:
COMPLETED
Pilot Trial of Microsphere Oxycodone (Xtampza ER) for Pain Management in Patients Receiving Radiotherapy for Locally Advanced Head and Neck Cancer
Lead Sponsor:
University of Alabama at Birmingham
Conditions:
Locally Advanced Head and Neck Cancer
Eligibility:
All Genders
19+ years
Phase:
EARLY_PHASE1
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 pai...
Eligibility Criteria
Inclusion
- 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
- \-
Key Trial Info
Start Date :
May 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 17 2020
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT03317730
Start Date
May 1 2018
End Date
November 17 2020
Last Update
July 20 2021
Active Locations (1)
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1
Hazelrig-Salter Radiation Oncology Center
Birmingham, Alabama, United States, 35233