Olanzapine Versus Aprepitant Based Antiemetic Regimen for High Emetic Chemotherapy
Randomized, Placebo-controlled Trial of Olanzapine Versus Aprepitant Plus Ondansetron and Dexamethasone as Antiemetic Prophylaxis in Patients Receiving High Emetic Chemotherapy
1 other identifier
interventional
147
1 country
2
Brief Summary
Aprepitant and olanzapine have been recommended for emesis prevention from highly emetogenic chemotherapy. We hypothesized that olanzapine may lead to less nausea compared to aprepitant based on previous study. However, data of combination of olanzapine and ondansetron is scarce.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Mar 2019
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2019
CompletedFirst Submitted
Initial submission to the registry
March 14, 2019
CompletedFirst Posted
Study publicly available on registry
March 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedMarch 15, 2019
March 1, 2019
1.4 years
March 14, 2019
March 14, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
no nausea rate
proportion of patients report no nausea
Days 1-5 of chemotherapy
Secondary Outcomes (2)
complete remission
Days 1-5 of chemotherapy
>= grade 3 vomiting
Days 1-5 of chemotherapy
Study Arms (3)
aprepitant
ACTIVE COMPARATORaprepitant / dexamethasone/ ondansetron
olanzapine 10 mg
EXPERIMENTALolanzapine 10 mg/dexamethasone/ ondansetron
olanzapine 5 mg
EXPERIMENTALolanzapine 5 mg/dexamethasone/ ondansetron
Interventions
aprepitant 125 mg orally, dexamethasone 12 mg iv, ondansetron 8 mg iv before chemotherapy aprepitant 80 mg orally D2-4, dexamethasone 8 mg/day orally D2-4
olanzapine 10 mg orally, dexamethasone 12 mg iv, ondansetron 8 mg iv before chemotherapy olanzapine 10 mg orally D2-4, dexamethasone 8 mg/day orally D2-4
olanzapine 5 mg orally, dexamethasone 12 mg iv, ondansetron 8 mg iv before chemotherapy olanzapine 5 mg orally D2-4, dexamethasone 8 mg/day orally D2-4
Eligibility Criteria
You may qualify if:
- pathologically proved of solid malignancy
- receive first cycle of cisplatin \>= 50 mg/m2 or cyclophosphamide/doxorubicin
You may not qualify if:
- pregnancy
- patients with episode of vomiting within 24 hours before starting chemotherapy
- uncontrolled brain/ CNS metastasis
- gut obstruction
- receive combination of moderate or high emetogenic chemotherapy during Day 2-5
- Known allergy to ondansetron, olanzapine, aprepitant or dexamethasone
- currently receive olanzapine with other indication and plan to continue the drug
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Division of medical oncology, department of medicine Siriraj Hospital
Bangkok, 10700, Thailand
Siriraj Hospital
Bangkok, 10700, Thailand
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Suthinee Ithimakin, MD
Mahidol University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 14, 2019
First Posted
March 15, 2019
Study Start
March 1, 2019
Primary Completion
August 1, 2020
Study Completion
December 1, 2020
Last Updated
March 15, 2019
Record last verified: 2019-03
Data Sharing
- IPD Sharing
- Will not share