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Olanzapine for Managing Anorexia in Head and Neck Cancer Patients Undergoing Chemoradiation, MACRO Trial
Sponsor: Roswell Park Cancer Institute
Summary
This phase II trial compares the effect of adding olanzapine to standard of care symptom management for nausea to standard of care alone in managing an abnormal loss of the appetite for food (anorexia) in patients treated with chemoradiation therapy (CRT) for head and neck cancer. Patients undergoing CRT may experience treatment-related side effects, including pain, nausea, and a discomfort in the ability to speak, swallow and eat. These side effects have been shown to increase weight loss, opiate use and hospitalization. Olanzapine is a drug used to treat certain mental disorders. It is also being studied in the treatment of nausea and vomiting caused by some cancer treatments. It is a type of anti-psychotic and a type of monoamine antagonist. Adding olanzapine to standard of care symptom management to limit nausea may be more effective than standard of care alone in managing anorexia in head and neck cancer patients during CRT.
Official title: Managing Anorexia During Chemoradiation With Olanzapine (MACRO)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
66
Start Date
2025-12-24
Completion Date
2031-11-15
Last Updated
2026-02-17
Healthy Volunteers
No
Conditions
Interventions
Best Practice
Given standard of care symptom management
Olanzapine
Given PO
Questionnaire Administration
Ancillary studies
Locations (1)
Roswell Park Cancer Institute
Buffalo, New York, United States