Managing Anorexia During Chemoradiation With Olanzapine (MACRO)
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.
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 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.
Arms & interventions
- OtherBest Practice
Given standard of care symptom management
- DrugOlanzapine
Given PO
- OtherQuestionnaire Administration
Ancillary studies
Outcome measures
Primary
Average change in weight
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.
Time frame: From baseline to patient lowest weight during chemoradiation therapy (CRT) treatment, assessed up to 5 weeks after last dose of study treatment
Secondary
Proportion of patients with severe weight loss
Time frame: At baseline up to any time point during CRT treatment, assessed up to 5 weeks after last dose of study treatment
Incidence of adverse events
Time frame: Up to 5 weeks after last dose of study treatment
Change in quality of life (QOL) scores
Time frame: Baseline up to 5 weeks after last dose of study treatment
Change in Quality of Life
Time frame: Up to 5 weeks after last dose of study treatment
Changes in sleep
Time frame: Baseline up to 5 weeks after last dose of study treatment
Opiate use
Time frame: Up to 5 weeks after last dose of study treatment
Hospitalization rate
Time frame: Up to 5 weeks after last dose of study treatment
Feeding tube use
Time frame: Up to 5 weeks after last dose of study treatment
Chemotherapy delays
Time frame: Up to 5 weeks after last dose of study treatment
Additional olanzapine prescriptions
Time frame: Up to 5 weeks after last dose of study treatment
Eligibility criteria
Study locations (1)
Roswell Park Cancer Institute
Buffalo, New York, 14263