RecruitingPhase 2NCT06995508

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

Managing Anorexia During Chemoradiation With Olanzapine (MACRO)

Sponsor

Roswell Park Cancer Institute

Enrollment

66 participants

Start Date

Dec 24, 2025

Study Type

INTERVENTIONAL

Conditions

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

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether olanzapine — a medication normally used for mental health conditions — can help head and neck cancer patients maintain their weight and appetite during chemoradiation (combined chemotherapy and radiation therapy), which often causes severe appetite loss. **You may be eligible if...** - You are 18 or older with a biopsy-confirmed squamous cell carcinoma of the head and neck - You are scheduled to receive chemoradiation with curative (not palliative) intent - Your doctor says you are well enough to tolerate chemotherapy (ECOG performance status 0–2) - You can swallow and keep down oral medication **You may NOT be eligible if...** - Your radiation therapy is only for symptom management (palliative), not for a cure - You already have a feeding tube - You regularly use steroids - You currently take antipsychotic medications - You have a history of seizures, uncontrolled heart disease, or uncontrolled diabetes - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERBest Practice

Given standard of care symptom management

DRUGOlanzapine

Given PO

OTHERQuestionnaire Administration

Ancillary studies

Locations(1)

Roswell Park Cancer Institute

Buffalo, New York, United States

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NCT06995508

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