Olanzapine for Chemotherapy-induced Nausea and Vomiting Prophylaxis (OLN-EME)

Rajavithi Hospital

Status and phase: Completed; Phase 3

Conditions: Complete Response Rate to Chemotherapy-induced Nausea and Vomiting Prophylaxis

Treatments: Drug: Placebo ORAL TABLET; Drug: Olanzapine 10 Mg ORAL TABLET; Drug: Olanzapine 5 Mg ORAL TABLET

Study type: Interventional

Funder types: Other

Identifiers

NCT04232423

162/2562

Details and patient eligibility

About

To investigate that olanzapine can reduced side effect about nausea and vomiting in women with gynecologic cancers receiving carboplatin-based regimen by using olanzapine and placebo

Full description

A double-blind, placebo-controlled, randomized crossover trial

Enrollment: 90 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Women with gynecological cancer receiving carboplatin-based chemotherapeutic regimen
• ECOG performance status 0-1
• Normal bone marrow, liver, and renal functions
• Can speak and write in Thai language

Exclusion criteria

• Women with nausea or vomiting prior to chemotherapeutic administration
• Pregnant women
• Women with active infection
• Women with bowel obstruction
• Women with symptomatic brain metastases
• Women who received dopamine receptor antagonists within 1 week before chemotherapeutic administration
• Women who received corticosteroid within 1 week before chemotherapeutic administration
• Women with past history of chemotherapy or radiotherapy
• Women with psychiatric disorders
• Women with poor controlled diabetes mellitus
• Women who received anticonvulsant medication
• Women with history of neuroleptic malignant syndrome
• Women with history of olanzapine allergy
• Women with history of lactose intolerance

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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90 participants in 3 patient groups

OLN 0-5-10

Experimental group

Description:

Placebo tablet in chemotherapy cycle 1, olanzapine 5 mg tablet in chemotherapy cycle 2, and olanzapine 10 mg tablet in chemotherapy cycle 3

Treatment:

Drug: Olanzapine 5 Mg ORAL TABLET

Drug: Olanzapine 10 Mg ORAL TABLET

Drug: Placebo ORAL TABLET

OLN 5-10-0

Experimental group

Description:

Olanzapine 5 mg tablet in chemotherapy cycle 1, olanzapine 10 mg tablet in chemotherapy cycle 2, and placebo tablet in chemotherapy cycle 3

Treatment:

Drug: Olanzapine 5 Mg ORAL TABLET

Drug: Olanzapine 10 Mg ORAL TABLET

Drug: Placebo ORAL TABLET

OLN 10-0-5

Experimental group

Description:

Olanzapine10 tablet in chemotherapy cycle 1, placebo tablet in chemotherapy cycle 2, and olanzapine 5 mg tablet in chemotherapy cycle 3

Treatment:

Drug: Olanzapine 5 Mg ORAL TABLET

Drug: Olanzapine 10 Mg ORAL TABLET

Drug: Placebo ORAL TABLET