Study of FOND Versus FOND+O for the Prevention of CINV in Hematology Patients Receiving Highly Emetogenic Chemotherapy Regimens

Hematologic Neoplasms Clinical Trial

— FOND-O  

Official title:

Randomized, Placebo Controlled Study of FOND (Fosaprepitant, Ondansetron, Dexamethasone) Versus FOND+O (FOND Plus Olanzapine) for the Prevention of Chemotherapy Induced Nausea and Vomiting in Hematology Patients Receiving Highly Emetogenic Chemotherapy Regimens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02635984
• Other study ID #: 818888
• Status: Completed
• Phase: Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Complications of Bone Marrow Transplant
• Hematologic Neoplasms

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