Olanzapine Versus Aprepitant Based Antiemetic Regimen for High Emetic Chemotherapy

Antiemetic for Highly Emetogenic Chemotherapy Clinical Trial

Official title:

Randomized, Placebo-controlled Trial of Olanzapine Versus Aprepitant Plus Ondansetron and Dexamethasone as Antiemetic Prophylaxis in Patients Receiving High Emetic Chemotherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03876938
• Other study ID #: 728/2561(EC4)
• Status: Recruiting
• Phase: Phase 3
• Start date: March 1, 2019
• Est. completion date: December 2020

Study information

• Verified date: March 2019
• Source: Mahidol University
• Contact: Suthinee Ithimakin, MD
• Phone: +6624194489
• Email: aesi105[@]yahoo.co.th
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 147
• Est. completion date: December 2020
• Est. primary completion date: August 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Antiemetic for Highly Emetogenic Chemotherapy

Intervention

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
• 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
• 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

Locations

Country	Name	City	State
Thailand	Division of medical oncology, department of medicine Siriraj Hospital	Bangkok
Thailand	Siriraj Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	no nausea rate	proportion of patients report no nausea	Days 1-5 of chemotherapy
Secondary	complete remission	no episode of vomiting	Days 1-5 of chemotherapy
Secondary	>= grade 3 vomiting	higher than grade 3 vomiting	Days 1-5 of chemotherapy