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Type(s) of Cancer
Leukemia, Multiple Myeloma, Lymphoma (Non-Hodgkins), Lymphoma (Hodgkins)
Study Phase
Phase 3
Study Completion Date
April 2015
NCT02116530Uploaded 02-12-2020
Access via NCI by Request
PDS UID - nci-data-402
Olanzapine for the Prevention of Chemotherapy Induced Nausea and Vomiting (CINV) in Patients Receiving Highly Emetogenic Chemotherapy (HEC): A Randomized, Double-Blind, Placebo-Controlled Trial
Provider Information
Provider Data DescriptionDataset NCT02116530-D2-Dataset.csv (aedat) is one of 2 datasets associated with PubMed ID 27410922. This dataset contains information that will allow you to reproduce the adverse events analyses. Due to cleaning efforts subsequent to the publication, the data contains some minor discrepancies from those reported in the manuscript.
SponsorAlliance for Clinical Trials in Oncology
Data ProviderNational Cancer Institute
Partial set or SubsetN/A
Patients in dataset401
# of Patients Control0
# of Patients ExperimentalNA
DOIN/A
CDISC StandardNCI standard
Study ArmsUndefined
Clinical Trials.gov Information
Brief SummaryThis randomized phase III trial studies antiemetic therapy with olanzapine to see how well they work compared to antiemetic therapy alone in preventing chemotherapy-induced nausea and vomiting in patients with cancer receiving highly emetogenic (causes vomiting) chemotherapy. Antiemetic drugs, such as palonosetron hydrochloride, ondansetron, and granisetron hydrochloride, may help lessen or prevent nausea and vomiting in patients treated with chemotherapy. Olanzapine may help prevent chemotherapy-induced nausea and vomiting by blocking brain receptors that appear to be involved in nausea and vomiting.
ConditionsHematopoietic/Lymphoid Cancer
Nausea and Vomiting
Unspecified Adult Solid Tumor, Protocol Specific
Intervention TypeDrug: Olanzapine
Drug: Chemotherapy (cisplatin or cyclophosphamide and doxorubicin)
Drug: Antiemetic treatment (ondansetron or granisetron or palonosetron; plus dexamethasone; plus fosaprepitant or aprepitant)
Other: Placebo
Drug(s)Drug: Olanzapine
Drug: Chemotherapy (cisplatin or cyclophosphamide and doxorubicin)
Drug: Antiemetic treatment (ondansetron or granisetron or palonosetron; plus dexamethasone; plus fosaprepitant or aprepitant)
Total Enrolled401
RandomizationRandomized
Blinding MethodDouble
Arms InterventionOlanzapine + Chemotherapy + Antiemetic treatment - Experimental
Placebo + Chemotherapy + Antiemetic treatment - Active Comparator
Secondary IDNCI-2014-00446
PubMed (PMID)27410922
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Age RangeMinimum Age: 18 Years
Maximum Age: NA
Files: NCT02116530-D2
Data DictionaryNCT02116530-D2-Data-Dictionary_2.pdf
DATANCT02116530-D2-Dataset_1.csv
OTHERREADME.pdf
Files: NCT02116530-D1
Data DictionaryNCT02116530-D1-Data-Dictionary_3.pdf
DATANCT02116530-D1-Dataset_1.csv
OTHERREADME.pdf
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