Olanzapine Versus Aprepitant Based Antiemetic Regimen for High Emetic Chemotherapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

147 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-01

Study Completion Date

2020-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Antiemetic for Highly Emetogenic Chemotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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aprepitant

aprepitant / dexamethasone/ ondansetron

Group Type ACTIVE_COMPARATOR

aprepitant

Intervention Type DRUG

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/dexamethasone/ ondansetron

Group Type EXPERIMENTAL

olanzapine 10 mg

Intervention Type DRUG

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/dexamethasone/ ondansetron

Group Type EXPERIMENTAL

olanzapine 5 mg

Intervention Type DRUG

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

Interventions

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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

Intervention Type 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

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No