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

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.

Inclusion criteria

• 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 criteria

• 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