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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02635984
Other study ID # 818888
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date November 2015
Est. completion date December 2017

Study information

Verified date July 2018
Source Augusta University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 108
Est. completion date December 2017
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Inpatient or outpatient hematology patient receiving one of the following regimens:

- Chemotherapy for hematologic malignancy:

- ABVD

- ICE ± R

- 7+3

- Conditioning therapy for stem cell transplantation:

- BEAM

- Bu/Cy ± ATG

- Bu/Flu ± ATG

- FluCy ± ATG

- FluCy + TBI

- BuMel

- FluBuCy

- Melphalan

- Etoposide + TBI

- Cyclophosphamide + TBI

Exclusion Criteria:

- Allergy to olanzapine

- Documented nausea or vomiting =24 hours prior to enrollment

- Treatment with other antipsychotic agents such as risperidone, quetiapine, clozapine, phenothiazine or butyrophenone =30 days prior to enrollment or planned during protocol therapy

- Chronic alcoholism

- Pregnant

- Declined or unable to provide an informed consent

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Olanzapine
Olanzapine 10mg by mouth once daily on all chemotherapy days and for three days post-chemotherapy
Placebo
Placebo tablet taken by mouth once daily on chemotherapy days and for 3 days post chemotherapy

Locations

Country Name City State
United States Augusta University Medical Center Augusta Georgia

Sponsors (2)

Lead Sponsor Collaborator
Augusta University University of Georgia

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Until study completion; estimated 1.5 years
Secondary 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 Until study completion; estimated 1.5 years
Secondary 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] Until study completion; estimated 1.5 years
Secondary 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 Until study completion; estimated 1.5 years
Secondary 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 Until study completion; estimated 1.5 years
Secondary 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) Until study completion; estimated 1.5 years
Secondary 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) Until study completion; estimated 1.5 years
Secondary 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) Until study completion; estimated 1.5 years
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