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

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.

NCT Number	NCT06995508
Lead Sponsor	Roswell Park Cancer Institute
Conditions	Cancer-Associated Anorexia, Head and Neck Squamous Cell Carcinoma, Neck Squamous Cell Carcinoma of Unknown Primary
Enrollment	66 participants
Start Date	2025-12-24
Primary Completion	2030-11-15 (estimated)
Study Completion	2031-11-15 (estimated)
Updated on ClinicalTrials.gov	2026-02-17