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

R

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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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