Study of FOND Versus FOND+O for the Prevention of CINV in Hematology Patients Receiving Highly Emetogenic Chemotherapy Regimens
| Status: | Completed |
|---|---|
| Conditions: | Blood Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/22/2018 |
| Start Date: | November 2015 |
| End Date: | December 2017 |
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
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.
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.
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.
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
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