Actively Recruiting
Olanzapine for Managing Anorexia in Head and Neck Cancer Patients Undergoing Chemoradiation, MACRO Trial
Led by Roswell Park Cancer Institute · Updated on 2026-02-17
66
Participants Needed
1
Research Sites
307 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Olanzapine for Managing Anorexia in Head and Neck Cancer Patients Undergoing Chemoradiation, MACRO Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Biopsy-proven squamous cell carcinoma of the head and neck, including neck squamous cell carcinoma of unknown primary site
- Eligible for curative-intent chemoradiation therapy of the head and neck
- Eligible for concurrent systemic therapy, preferably platinum-based chemotherapy, as determined by treating oncologist
- Ability to swallow and retain oral medication
- If of child-bearing potential, agree to use effective contraceptive methods before study entry
- Agree to avoid taking Symbyax, consuming alcohol, and operating hazardous machinery while on olanzapine during the study
- Understand the investigational nature of the study and sign informed consent before any study procedures
You will not qualify if you...
- Eligible only for palliative-intent radiation therapy
- Presence of a feeding tube
- Regular use of systemic steroids
- Use of atypical antipsychotic medications
- Uncontrolled illness such as active infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, diabetes, psychiatric illness, or social situations limiting compliance
- Known allergy to olanzapine
- Pregnant or nursing female participants
- History of seizures
- Unwilling or unable to follow study protocol requirements
- Any condition that the investigator considers makes the participant unsuitable for study drug
AI-Screening
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Trial Site Locations
Total: 1 location
1
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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