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Olanzapine for Anorexia in Head and Neck Cancer Patients

This study, called the MACRO Trial, is looking at whether adding olanzapine to standard care can help head and neck cancer patients undergoing chemoradiation (a combination of chemotherapy and radiation therapy) manage anorexia (abnormal loss of appetite). Chemoradiation can cause side effects like pain, nausea, and difficulty eating, which can lead to weight loss. Olanzapine is a medication used for some mental health conditions and is also being studied for treating nausea and vomiting. This trial aims to see if olanzapine can prevent weight loss in these patients. The study plans to enroll 66 participants who are at least 18 years old and have been diagnosed with head and neck squamous cell carcinoma. The main goal is to measure the average change in weight during and after chemoradiation.

Study design
This is an interventional study where participants will be randomly assigned to one of two groups: one receiving standard symptom management, and the other receiving olanzapine in addition to standard symptom management.
What's involved
Participants will receive either standard care or olanzapine daily for up to 10 weeks after completing chemoradiation. They will also complete questionnaires.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed up at 5 weeks after completing the study treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06995508

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Roswell Park Cancer Institute
~66 participants
Updated 2026-08-18 on ClinicalTrials.gov
What's tested:Best PracticeOlanzapineQuestionnaire Administration

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Average change in weight
Measured over From baseline to patient lowest weight during chemoradiation therapy (CRT) treatment, assessed up to 5 weeks after last dose of study treatment

Conditions

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

Explore related trials

Cancer-Associated AnorexiaHead and Neck Squamous Cell CarcinomaSquamous Cell Carcinoma of Unknown Primary

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Anurag K Singh · PRINCIPAL_INVESTIGATOR · Roswell Park Cancer Institute

Who to contact

Anurag K. Singh
[email protected]
716-845-1179
Email the study team

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Do you actually qualify for this trial?

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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
Participants must agree to avoid the following while taking Olanzapine while they are on study:
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

What this trial measures

  • Average change in weightFrom baseline to patient lowest weight during chemoradiation therapy (CRT) treatment, assessed up to 5 weeks after last dose of study treatment

    Will be summarized by study arm using the mean and standard deviation. A two-sample t-test will be used. All test assumptions will be verified graphically, and transformations or non-parametric approaches will be considered, as appropriate.