This phase III trial compares the effect of adding olanzapine to standard anti-vomiting therapy versus standard anti-vomiting therapy alone in preventing chemotherapy induced nausea and vomiting in cancer patients undergoing a stem cell transplant. Giving olanzapine together with other anti-nausea medication may reduce the frequency or severity of chemotherapy induced nausea and vomiting.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04535141.
PRIMARY OBJECTIVE:
I. To compare the overall rate of complete response (CR) between patients on study treatment [experimental arm], defined as receiving olanzapine plus standard three drug chemotherapy induced nausea and vomiting (CINV) prophylaxis regimen, and patients receiving usual care [standard of care arm], defined as receiving placebo plus standard three drug CINV prophylaxis during the study assessment period.
SECONDARY OBJECTIVES:
I. To compare the total number of rescue medications needed for breakthrough CINV between the experimental and standard of care arms for the same assessment period.
II. To compare the number of patients achieving minimal nausea between the experimental and standard of care arms for the same assessment period for the same assessment period.
III. To compare the patient reported frequency of nausea between patients on the experimental and standard of care arms for the same assessment period for the same assessment period.
IV. To compare the patient reported severity of nausea between patients the experimental and standard of care arms for the same assessment period for the same assessment period.
V. To compare number of episodes of emesis between patients the experimental and standard of care arms for the same assessment period for the same assessment period.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive olanzapine orally (PO) beginning with the first dose of conditioning chemotherapy to 3 days after the last dose of conditioning chemotherapy for up to 10 days in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive placebo PO beginning with the first dose of conditioning chemotherapy to 3 days after the last dose of conditioning chemotherapy for up to 10 days in the absence of disease progression or unacceptable toxicity.
After completion of study, patients are followed up at 4 and 5 days after chemotherapy.
Trial PhasePhase III
Trial Typesupportive care
Lead OrganizationUNC Lineberger Comprehensive Cancer Center
Principal InvestigatorJonathan Ptachcinski
