Status:
NOT_YET_RECRUITING
Olanzapine for Managing Anorexia in Head and Neck Cancer Patients Undergoing Chemoradiation, MACRO Trial
Lead Sponsor:
Roswell Park Cancer Institute
Conditions:
Cancer-Associated Anorexia
Head and Neck Squamous Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
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 olan...
Eligibility Criteria
Inclusion
- Age ≥ 18 years old
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
- Diagnosed with biopsy-proven, squamous cell carcinoma of the head and neck, including squamous cell carcinoma of the neck with unknown primary site
- Eligible for curative-intent chemoradiation therapy of the head and neck
- Patients must be eligible for concurrent systemic therapy (preferably platinum based) as determined by the treating medical oncologist to undergo platinum-based chemotherapy
- Ability to swallow and retain oral medication
- Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
- While you are on study and taking olanzapine, you agree to avoid the following:
- Taking the drug Symbyax (which already contains olanzapine)
- Consuming alcohol
- Operating hazardous machinery, including automobiles, until you are reasonably certain that the study drug therapy does not have any bad effects on your mental and physical health
- Participant must understand the investigational nature of this study and sign an institutional review board approved written informed consent form prior to receiving any study related procedure
Exclusion
- Eligible for palliative-intent radiation therapy only
- Patients with a feeding tube
- Regular systemic steroid use
- Atypical antipsychotic use
- Other dopamine receptor blockers routinely used as anti-emetics (eg. prochlorperazine/compazine and metoclopramide) are allowed to be prescribed as usual care on this study
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, diabetes or psychiatric illness/social situations that would limit compliance with study requirements
- Known hypersensitivity to olanzapine
- Pregnant or nursing female participants
- Known history of seizures
- Unwilling or unable to follow protocol requirements
- Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug
Key Trial Info
Start Date :
January 15 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 15 2031
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT06995508
Start Date
January 15 2026
End Date
November 15 2031
Last Update
December 15 2025
Active Locations (1)
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1
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263