Back to resultsOlanzapine for Chemotherapy-induced Nausea and Vomiting Prophylaxis (OLN-EME)
Primary Purpose
Complete Response Rate to Chemotherapy-induced Nausea and Vomiting Prophylaxis
Status
Completed
Phase
Phase 3
Locations
Thailand
Study Type
Interventional
Intervention
Olanzapine 10 Mg ORAL TABLET
Olanzapine 5 Mg ORAL TABLET
Placebo ORAL TABLET
Sponsored by
About this trial
This is an interventional treatment trial for Complete Response Rate to Chemotherapy-induced Nausea and Vomiting Prophylaxis focused on measuring Olanzapine, Chemotherapy-induced nausea and vomiting, Carboplatin, Gynecologic cancer
Eligibility Criteria
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
Sites / Locations
- Rajavithi hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
OLN 0-5-10
OLN 5-10-0
OLN 10-0-5
Arm Description
Placebo tablet in chemotherapy cycle 1, olanzapine 5 mg tablet in chemotherapy cycle 2, and olanzapine 10 mg tablet in chemotherapy cycle 3
Olanzapine 5 mg tablet in chemotherapy cycle 1, olanzapine 10 mg tablet in chemotherapy cycle 2, and placebo tablet in chemotherapy cycle 3
Olanzapine10 tablet in chemotherapy cycle 1, placebo tablet in chemotherapy cycle 2, and olanzapine 5 mg tablet in chemotherapy cycle 3
Outcomes
Primary Outcome Measures
Complete response rate of chemotherapy-induced nausea and vomiting prophylaxis
No breakthrough vomiting and no using rescue therapy
Secondary Outcome Measures
Episodes of vomiting
Severity of nausea
Use of rescue drug
using of rescue anti-emetic medication
Quality of life associated with nausea and vomiting measured using Functional Living Index-Emesis (FILE)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04232423
Brief Title
Olanzapine for Chemotherapy-induced Nausea and Vomiting Prophylaxis
Acronym
OLN-EME
Official Title
Efficacy and Dosage of Olanzapine for Chemotherapy-induced Nausea and Vomiting Prophylaxis in Women With Gynecologic Cancers Receiving Carboplatin-based Regimen : a Double-blind, Placebo-controlled, Randomized Crossover Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
September 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rajavithi Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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
Detailed Description
A double-blind, placebo-controlled, randomized crossover trial
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complete Response Rate to Chemotherapy-induced Nausea and Vomiting Prophylaxis
Keywords
Olanzapine, Chemotherapy-induced nausea and vomiting, Carboplatin, Gynecologic cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Model Description
A Double-Blind, Placebo-Controlled, Randomized Crossover Trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
OLN 0-5-10
Arm Type
Experimental
Arm Description
Placebo tablet in chemotherapy cycle 1, olanzapine 5 mg tablet in chemotherapy cycle 2, and olanzapine 10 mg tablet in chemotherapy cycle 3
Arm Title
OLN 5-10-0
Arm Type
Experimental
Arm Description
Olanzapine 5 mg tablet in chemotherapy cycle 1, olanzapine 10 mg tablet in chemotherapy cycle 2, and placebo tablet in chemotherapy cycle 3
Arm Title
OLN 10-0-5
Arm Type
Experimental
Arm Description
Olanzapine10 tablet in chemotherapy cycle 1, placebo tablet in chemotherapy cycle 2, and olanzapine 5 mg tablet in chemotherapy cycle 3
Intervention Type
Drug
Intervention Name(s)
Olanzapine 10 Mg ORAL TABLET
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Olanzapine 5 Mg ORAL TABLET
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo ORAL TABLET
Intervention Description
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
Primary Outcome Measure Information:
Title
Complete response rate of chemotherapy-induced nausea and vomiting prophylaxis
Description
No breakthrough vomiting and no using rescue therapy
Time Frame
5 days after chemotherapeutic administration
Secondary Outcome Measure Information:
Title
Episodes of vomiting
Time Frame
5 days after chemotherapeutic administration
Title
Severity of nausea
Time Frame
5 days after chemotherapeutic administration
Title
Use of rescue drug
Description
using of rescue anti-emetic medication
Time Frame
5 days after chemotherapeutic administration
Title
Quality of life associated with nausea and vomiting measured using Functional Living Index-Emesis (FILE)
Time Frame
5 days after chemotherapeutic administration
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Rajavithi hospital
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
12. IPD Sharing Statement
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Olanzapine for Chemotherapy-induced Nausea and Vomiting Prophylaxis
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