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Status unknownNCT03876938Updated Mar 15, 2019

Olanzapine Versus Aprepitant Based Antiemetic Regimen for High Emetic Chemotherapy

A Phase 3 interventional study of aprepitant and olanzapine 10 mg in Antiemetic for Highly Emetogenic Chemotherapy, sponsored by Mahidol University. Status unknown at 2 sites in Thailand. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-03-15.

Sponsored by Mahidol University · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
147
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

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Conditions studied

  • Antiemetic for Highly Emetogenic Chemotherapy
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In context

Lead sponsor

Mahidol University is the lead sponsor of 730 studies on the registry; 118 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
147 participants (estimated)

Study arms

  • Active comparator
    aprepitant

    aprepitant / dexamethasone/ ondansetron

    Drug: aprepitant

  • Experimental
    olanzapine 10 mg

    olanzapine 10 mg/dexamethasone/ ondansetron

    Drug: olanzapine 10 mg

  • Experimental
    olanzapine 5 mg

    olanzapine 5 mg/dexamethasone/ ondansetron

    Drug: olanzapine 5 mg

Interventions

  • Drugaprepitant

    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

  • Drugolanzapine 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

  • Drugolanzapine 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

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What researchers measure

Primary outcomes

  1. no nausea rate

    proportion of patients report no nausea

    Time frame: Days 1-5 of chemotherapy

Secondary outcomes

  1. complete remission

    no episode of vomiting

    Time frame: Days 1-5 of chemotherapy

  2. >= grade 3 vomiting

    higher than grade 3 vomiting

    Time frame: Days 1-5 of chemotherapy

07

Study locations

2 of 2 sites recruiting
  • Division of medical oncology, department of medicine Siriraj Hospital
    Bangkok, 10700, Thailand
    • Suthinee Ithimakin, MD · Contact · aesi105@yahoo.co.th · 662-419-4489
    • Suthinee Ithimakin, MD · Principal investigator
    • Pathra Theeratrakul, MD · Sub investigator
    • Apirom Laocharoenkiat · Sub investigator
    • Charuwan Akewanlop, MD · Sub investigator
    • Akarin Nimmannit, MD · Sub investigator
    Recruiting
  • Siriraj Hospital
    Bangkok, 10700, Thailand
    • Suthinee Ithimakin, MD · Contact
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 15, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03876938
Lead sponsor
Mahidol University
Responsible party
Sponsor
First posted
Mar 15, 2019
Start date
Mar 1, 2019
Primary completion
Aug 2020 (estimated)
Completion
Dec 2020 (estimated)
Last update
Mar 15, 2019

Study contacts

Suthinee Ithimakin, MD
Contact
aesi105@yahoo.co.th
+6624194489
Suthinee Ithimakin, MD
principal investigator · Mahidol University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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