Olanzapine Versus Aprepitant Based Antiemetic Regimen for High Emetic Chemotherapy

Mahidol University

Status and phase: Unknown; Phase 3

Conditions: Antiemetic for Highly Emetogenic Chemotherapy

Treatments: Drug: olanzapine 5 mg; Drug: olanzapine 10 mg; Drug: aprepitant

Study type: Interventional

Funder types: Other

Identifiers

NCT03876938

728/2561(EC4)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 147 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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147 participants in 3 patient groups

aprepitant

Active Comparator group

Description:

aprepitant / dexamethasone/ ondansetron

Treatment:

Drug: aprepitant

olanzapine 10 mg

Experimental group

Description:

olanzapine 10 mg/dexamethasone/ ondansetron

Treatment:

Drug: olanzapine 10 mg

olanzapine 5 mg

Experimental group

Description:

olanzapine 5 mg/dexamethasone/ ondansetron

Treatment:

Drug: olanzapine 5 mg