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
Overview
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Rajavithi Hospital
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Complete response rate of chemotherapy-induced nausea and vomiting prophylaxis
Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
OLN 0-5-10
Placebo tablet in chemotherapy cycle 1, olanzapine 5 mg tablet in chemotherapy cycle 2, and olanzapine 10 mg tablet in chemotherapy cycle 3
Intervention: Olanzapine 10 Mg ORAL TABLET (Drug)
OLN 0-5-10
Placebo tablet in chemotherapy cycle 1, olanzapine 5 mg tablet in chemotherapy cycle 2, and olanzapine 10 mg tablet in chemotherapy cycle 3
Intervention: Olanzapine 5 Mg ORAL TABLET (Drug)
OLN 0-5-10
Placebo tablet in chemotherapy cycle 1, olanzapine 5 mg tablet in chemotherapy cycle 2, and olanzapine 10 mg tablet in chemotherapy cycle 3
Intervention: Placebo ORAL TABLET (Drug)
OLN 5-10-0
Olanzapine 5 mg tablet in chemotherapy cycle 1, olanzapine 10 mg tablet in chemotherapy cycle 2, and placebo tablet in chemotherapy cycle 3
Intervention: Olanzapine 10 Mg ORAL TABLET (Drug)
OLN 5-10-0
Olanzapine 5 mg tablet in chemotherapy cycle 1, olanzapine 10 mg tablet in chemotherapy cycle 2, and placebo tablet in chemotherapy cycle 3
Intervention: Olanzapine 5 Mg ORAL TABLET (Drug)
OLN 5-10-0
Olanzapine 5 mg tablet in chemotherapy cycle 1, olanzapine 10 mg tablet in chemotherapy cycle 2, and placebo tablet in chemotherapy cycle 3
Intervention: Placebo ORAL TABLET (Drug)
OLN 10-0-5
Olanzapine10 tablet in chemotherapy cycle 1, placebo tablet in chemotherapy cycle 2, and olanzapine 5 mg tablet in chemotherapy cycle 3
Intervention: Olanzapine 10 Mg ORAL TABLET (Drug)
OLN 10-0-5
Olanzapine10 tablet in chemotherapy cycle 1, placebo tablet in chemotherapy cycle 2, and olanzapine 5 mg tablet in chemotherapy cycle 3
Intervention: Olanzapine 5 Mg ORAL TABLET (Drug)
OLN 10-0-5
Olanzapine10 tablet in chemotherapy cycle 1, placebo tablet in chemotherapy cycle 2, and olanzapine 5 mg tablet in chemotherapy cycle 3
Intervention: Placebo ORAL TABLET (Drug)
Outcomes
Primary Outcomes
Complete response rate of chemotherapy-induced nausea and vomiting prophylaxis
Time Frame: 5 days after chemotherapeutic administration
No breakthrough vomiting and no using rescue therapy
Secondary Outcomes
- Episodes of vomiting(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)
- Severity of nausea(5 days after chemotherapeutic administration)