NCT06995508

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

Managing Anorexia During Chemoradiation With Olanzapine (MACRO)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVE: I. To assess the effect of adding olanzapine to standard symptom management on preventing weight loss during chemoradiation. SECONDARY OBJECTIVES: I. To assess the effect of olanzapine on: * Preventing severe weight loss; * The rate of toxicities-unrelated, possibly- or probably- related to the symptom management regimen (regardless of causality) II, Quality of Life (QOL) scores: * With particular attention to nausea, vomiting, appetite, loss, swallowing, pain; and Special attention to sleep; * Opiate use, hospitalization rate, feeding tube use, chemotherapy delays, and additional olanzapine prescriptions. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive standard of care symptom management on study per the discretion of the treating institution. ARM II: Starting day 1 of CRT, patients receive olanzapine PO QD for up to 10 weeks after completion of CRT in the absence of disease progression or unacceptable toxicity. Patients also receive standard of care symptom management on study per the discretion of the treating institution. After completion of study treatment, patients are followed up at 5 weeks.

Conditions

• Cancer-Associated Anorexia
• Head and Neck Squamous Cell Carcinoma
• Neck Squamous Cell Carcinoma of Unknown Primary

Interventions

Type	Name	Description
OTHER	Best Practice	Given standard of care symptom management
DRUG	Olanzapine	Given PO
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2025-12-24
• Primary completion: 2030-11-15
• Completion: 2031-11-15
• First posted: 2025-05-29
• Last updated: 2026-02-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study