Olanzapine for Chemotherapy-induced Nausea and Vomiting Prophylaxis

NCT04232423 | Completed Phase 3 DMC

• 1 other identifier: 162/2562
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Complete Response Rate to Chemotherapy-induced Nausea and Vomiting Prophylaxis

Keywords

Olanzapine; Chemotherapy-induced nausea and vomiting; Carboplatin; Gynecologic cancer

Outcome Measures

Primary Outcomes (1)

• Complete response rate of chemotherapy-induced nausea and vomiting prophylaxis

  No breakthrough vomiting and no using rescue therapy

  5 days after chemotherapeutic administration

Secondary Outcomes (4)

• Episodes of vomiting

  5 days after chemotherapeutic administration

• Severity of nausea

  5 days after chemotherapeutic administration

• Use of rescue drug

  5 days after chemotherapeutic administration

• Quality of life associated with nausea and vomiting measured using Functional Living Index-Emesis (FILE)

  5 days after chemotherapeutic administration

Study Arms (3)

OLN 0-5-10

EXPERIMENTAL

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

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

OLN 5-10-0

EXPERIMENTAL

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

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

OLN 10-0-5

EXPERIMENTAL

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

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

Interventions

Olanzapine 10 Mg ORAL TABLET DRUG

* Olanzapine 10 mg orally, ondansetron 8 mg intravenously, and dexamethazone 8 mg intravenously 30 minutes before chemotherapeutic administration (day 1) * Olanzapine 10 mg orally daily and dexamethazone 8 mg orally daily on day 2, 3, 4

OLN 0-5-10; OLN 10-0-5; OLN 5-10-0

Olanzapine 5 Mg ORAL TABLET DRUG

* Olanzapine 5 mg orally, ondansetron 8 mg intravenously, and dexamethazone 8 mg intravenously 30 minutes before chemotherapeutic administration (day 1) * Olanzapine 5 mg orally daily and dexamethazone 8 mg orally daily on day 2, 3, 4

OLN 0-5-10; OLN 10-0-5; OLN 5-10-0

Placebo ORAL TABLET DRUG

* Placebo 1 tab orally, ondansetron 8 mg intravenously, and dexamethazone 8 mg intravenously 30 minutes before chemotherapeutic administration (day 1) * Placebo 1 tab orally daily and dexamethazone 8 mg orally daily on day 2, 3, 4

OLN 0-5-10; OLN 10-0-5; OLN 5-10-0

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Department of Medical Services Ministry of Public Health of Thailand: lead

Study Sites (1)

Rajavithi hospital

Bangkok, 10400, Thailand

Location

MeSH Terms

Conditions

Vomiting

Interventions

Olanzapine; Tablets

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: A Double-Blind, Placebo-Controlled, Randomized Crossover Trial

Study Record Dates

• First Submitted: January 14, 2020
• First Posted: January 18, 2020
• Study Start: March 1, 2020
• Primary Completion: June 30, 2021
• Study Completion: September 30, 2021
• Last Updated: January 21, 2022

Record last verified: 2021-07

Locations

TH (1)