Managing Anorexia During Chemoradiation With Olanzapine (MACRO)
Managing Anorexia During Chemoradiation With Olanzapine (MACRO)
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.
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:
II, Quality of Life (QOL) scores:
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:
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
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