The objective of this study is to compare the effectiveness of olanzapine added to standard triplet therapy (fosaprepitant, ondansetron, and dexamethasone) versus triplet therapy alone in preventing chemotherapy-induced nausea and vomiting (CINV) in hematology patients receiving highly or moderately emetogenic chemotherapy regimens.
Nausea and vomiting remains a common and difficult to manage consequence of chemotherapy despite prophylaxis. These symptoms can often lead to a decreased quality of life, dehydration, and malnutrition. Olanzapine is an atypical antipsychotic that blocks multiple neuronal receptors involved in nausea/vomiting pathways. Olanzapine has been studied for breakthrough chemo-induced nausea and vomiting (CINV) as well as in prophylaxis of highly and moderately emetogenic regimens (HEC and MEC, respectively). However, these studies have focused on patients with solid tumor malignancies and chemotherapy regimens of short duration. To date, no publications have reported outcomes from adding olanzapine to standard triplet therapy, for hematology patients, including those undergoing hematopoietic stem cell transplants and those who receive multi-day HEC and MEC regimens. This is a blinded, placebo controlled trial randomizing patients to receive olanzapine 10 mg orally on all chemotherapy days plus three additional days post chemotherapy or placebo in addition to standard triplet therapy (ondansetron and dexamethasone on each day of chemotherapy and fosaprepitant 150 mg IV on day one of chemotherapy). Inclusion criteria: age 18 or older, receiving inpatient or outpatient HEC or MEC chemotherapy including those regimens given before stem cell transplantation (ABVD, ICE ± R, 7+3 or 5+2, BEAM, Bu/Cy ± ATG, Bu/Flu ± ATG, FluCy ± ATG, BuMel, FluBuCy, Melphalan). Exclusion criteria: allergy to olanzapine, documented nausea/vomiting ≤24 hours before enrollment, treatment with other antipsychotic agents, or declined informed consent. Patients will be randomized to placebo or olanzapine in a block design stratified by chemotherapy type (transplant conditioning vs. chemotherapy only) and number of days of chemotherapy (single vs. multi-day) by the Investigational Drug Pharmacy services at Augusta University Medical Center.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Enrollment
108
Olanzapine 10mg by mouth once daily on all chemotherapy days and for three days post-chemotherapy
Placebo tablet taken by mouth once daily on chemotherapy days and for 3 days post chemotherapy
Augusta University Medical Center
Augusta, Georgia, United States
Overall Percentage of Patients Who Had a Complete Response
Overall percentage of patients who had a complete response (CR) defined as no emesis and minimal nausea (\< 25 mm on a 100 mm visual analog scale \[VAS\]) during the overall assessment period (starting day 1 of chemotherapy and continuing for 5 days after discontinuation of chemotherapy) for the first cycle of chemotherapy.
Time frame: Until study completion; estimated 1.5 years
Percent of Patients With no Significant Nausea in Overall Assessment Period
Reported for overall phases \[chemotherapy days plus 5 days after\] where all VAS \< 25 mm
Time frame: Until study completion; estimated 1.5 years
Percent of Patients Achieving Complete Protection in Overall Assessment Phase
(CP = no emesis, no breakthrough antiemetic use, no significant nausea). To be reported as overall phases \[chemotherapy days plus 5 days after\]
Time frame: Until study completion; estimated 1.5 years
Percent of Participants With no Significant Nausea in Acute Phase
Reported as acute \[chemotherapy days\]. All assessment with all VAS \< 25 mm on days of chemotherapy
Time frame: Until study completion; estimated 1.5 years
Percent of Participants With no Significant Nausea in Delayed Phase
Reported for delayed \[5 days after chemotherapy administration\] All assessment with all VAS \< 25 mm
Time frame: Until study completion; estimated 1.5 years
Percent of Patients With no Nausea in Overall Assessment Period
No nausea (all VAS \<5 mm) in overall assessment period (days of chemotherapy plus five days after)
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Time frame: Until study completion; estimated 1.5 years
Percent of Patients With Complete Response in Acute Phase
Complete response (no emesis and no more than minimal nausea, defined as \< 25 mm on a 100 mm visual analog scale \[VAS\]) in acute phase (days of chemotherapy)
Time frame: Until study completion; estimated 1.5 years
Percent of Patients With Complete Response in Delayed Phase
Complete response (no emesis and no more than minimal nausea, defined as \< 25 mm on a 100 mm visual analog scale \[VAS\]) in delayed phase (5 days after chemotherapy)
Time frame: Until study completion; estimated 1.5 years