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

Completed · Early Phase 1

Conditions studied: Locally Advanced Head and Neck Cancer

In brief

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

Key facts

Study ID

NCT03317730

Run by

University of Alabama at Birmingham

People needed

28

Starts

2018-05-01

Expected to finish

2020-11-17

Last updated by the study team

2021-07-20

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• Hazelrig-Salter Radiation Oncology Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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