Hematologic Neoplasms Clinical Trial
— FOND-OOfficial 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
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 |
Verified date | July 2018 |
Source | Augusta University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Augusta University Medical Center | Augusta | Georgia |
Lead Sponsor | Collaborator |
---|---|
Augusta University | University of Georgia |
United States,
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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