Pilot Trial of Microsphere Oxycodone (Xtampza ER) for Pain Management in Patients Receiving Radiotherapy for Locally Advanced Head and Neck Cancer
| Status: | Recruiting |
|---|---|
| Conditions: | Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 19 - Any |
| Updated: | 5/24/2018 |
| Start Date: | May 1, 2018 |
| End Date: | December 2019 |
| Contact: | Valerie P Powell |
| Email: | vpowell@uabmc.edu |
| Phone: | 205-975-9316 |
To confirm the feasibility of studying Xtampza ER during radiotherapy (RT) for LAHNC as part
of a prospective clinical trial.
of a prospective clinical trial.
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.
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.
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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