Olanzapine for Managing Anorexia in Head and Neck Cancer Patients Undergoing Chemoradiation, MACRO Trial

Study 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.

Primary Outcome

Will be summarized by study arm using the mean and standard deviation. A two-sample t-test will be used. All test assumptions will be verified graphically, and transformations or non-parametric approaches will be considered, as appropriate.

Conditions Studied

Interventions

• OTHER Questionnaire Administration
• OTHER Best Practice
• DRUG Olanzapine

Study Locations (1)