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Olanzapine for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Chinese Breast Cancer Patients

NCT03079219 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2021-07-28

No results posted yet for this study

Summary

The Olanzapine Regimen will be superior to the Standard Regimen, as measured by the proportion of patients with Complete Response in the 120 hours following AC chemotherapy.

Conditions

Interventions

DRUG

Experimental drug: Aprepitant

Day 1: 125mg QD; Day 2 to Day 3: 80mg QD

DRUG

Experimental drug: Ondansetron

Day 1: 8mg BD, First dose 8mg, Second dose 8mg, 8 hours after first dose

DRUG

Experimental drug: Dexamethasone

Day 1: 12mg QD

DRUG

Experimental drug: Olanzapine

Day 1 to Day 5: 10mg QD

DRUG

Standard: Aprepitant

Day 1: 125mg QD, Day 2 to Day3: 80mg QD

DRUG

Standard: Ondansetron

Day 1: 8mg BD, First dose 8mg, second dose 8mg, 8 hours after first dose

DRUG

Standard: Dexamethasone

Day 1: 12mg QD ; Day 2 to Day 3: 4mg BD

Sponsors & Collaborators

  • CCTU

    lead OTHER

Principal Investigators

  • Winnie Yeo, MD, FRCP · Chinese University of Hong Kong

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
74 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-23
Primary Completion
2021-03-01
Completion
2021-03-01

Countries

  • Hong Kong

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03079219 on ClinicalTrials.gov