Managing Anorexia During Chemoradiation With Olanzapine (MACRO)
Roswell Park Cancer Institute
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) 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.
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 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, an…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- OtherBest Practice
Given standard of care symptom management
- DrugOlanzapine
Given PO
- OtherQuestionnaire Administration
Ancillary studies
Location
- Roswell Park Cancer InstituteBuffalo, New York