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
A double-blind, placebo-controlled, randomized crossover trial
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
90
* 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
* 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
* 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
Rajavithi hospital
Bangkok, Thailand
Complete response rate of chemotherapy-induced nausea and vomiting prophylaxis
No breakthrough vomiting and no using rescue therapy
Time frame: 5 days after chemotherapeutic administration
Episodes of vomiting
Time frame: 5 days after chemotherapeutic administration
Severity of nausea
Time frame: 5 days after chemotherapeutic administration
Use of rescue drug
using of rescue anti-emetic medication
Time frame: 5 days after chemotherapeutic administration
Quality of life associated with nausea and vomiting measured using Functional Living Index-Emesis (FILE)
Time frame: 5 days after chemotherapeutic administration
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