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Olanzapine Versus Aprepitant Based Antiemetic Regimen for High Emetic Chemotherapy

Sponsor
Mahidol University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03876938
Collaborator
(none)
147
Enrollment
2
Locations
3
Arms
21.1
Anticipated Duration (Months)
73.5
Patients Per Site
3.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

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 on efficacy and adverse effects of combination of olanzapine and ondansetron which is only serotonin antagonist in Thai national essential drug list, is scarce. Also, we aims to assess the efficacy of olanzapine dosage of 5 mg which is more commonly used in Thai patients.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
147 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Randomized, Placebo-controlled Trial of Olanzapine Versus Aprepitant Plus Ondansetron and Dexamethasone as Antiemetic Prophylaxis in Patients Receiving High Emetic Chemotherapy
Actual Study Start Date :
Mar 1, 2019
Anticipated Primary Completion Date :
Aug 1, 2020
Anticipated Study Completion Date :
Dec 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: aprepitant

aprepitant / dexamethasone/ ondansetron

Drug: aprepitant
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
Experimental: olanzapine 10 mg

olanzapine 10 mg/dexamethasone/ ondansetron

Drug: olanzapine 10 mg
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
Experimental: olanzapine 5 mg

olanzapine 5 mg/dexamethasone/ ondansetron

Drug: olanzapine 5 mg
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

Outcome Measures

Primary Outcome Measures

  1. no nausea rate [Days 1-5 of chemotherapy]

    proportion of patients report no nausea

Secondary Outcome Measures

  1. complete remission [Days 1-5 of chemotherapy]

    no episode of vomiting

  2. >= grade 3 vomiting [Days 1-5 of chemotherapy]

    higher than grade 3 vomiting

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • pathologically proved of solid malignancy

  • receive first cycle of cisplatin >= 50 mg/m2 or cyclophosphamide/doxorubicin

Exclusion Criteria:

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Division of medical oncology, department of medicine Siriraj Hospital Bangkok Thailand 10700
2 Siriraj Hospital Bangkok Thailand 10700

Sponsors and Collaborators

  • Mahidol University

Investigators

  • Principal Investigator: Suthinee Ithimakin, MD, Mahidol University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mahidol University
ClinicalTrials.gov Identifier:
NCT03876938
Other Study ID Numbers:
  • 728/2561(EC4)
First Posted:
Mar 15, 2019
Last Update Posted:
Mar 15, 2019
Last Verified:
Mar 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Olanzapine
Aprepitant

Study Results

No Results Posted as of Mar 15, 2019