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RECRUITING
NCT06995508
PHASE2

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

Sponsor: Roswell Park Cancer Institute

View on ClinicalTrials.gov

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

Interventions

OTHER

Best Practice

Given standard of care symptom management

DRUG

Olanzapine

Given PO

OTHER

Questionnaire Administration

Ancillary studies

Locations (1)

Roswell Park Cancer Institute

Buffalo, New York, United States