Complete Response Rate to Chemotherapy-induced Nausea and Vomiting Prophylaxis
Conditions
Keywords
Olanzapine, Chemotherapy-induced nausea and vomiting, Carboplatin, Gynecologic cancer
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
Interventions
DRUGOlanzapine 10 Mg ORAL TABLET
* 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
DRUGPlacebo ORAL TABLET
* 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
Sponsors
Department of Medical Services Ministry of Public Health of Thailand
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
A Double-Blind, Placebo-Controlled, Randomized Crossover Trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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 * Women who received anticonvulsant medication * Women with history of neuroleptic malignant syndrome * Women with history of olanzapine allergy * Women with history of lactose intolerance
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete response rate of chemotherapy-induced nausea and vomiting prophylaxis | 5 days after chemotherapeutic administration | No breakthrough vomiting and no using rescue therapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | using of rescue anti-emetic medication |
| Quality of life associated with nausea and vomiting measured using Functional Living Index-Emesis (FILE) | 5 days after chemotherapeutic administration | — |
Countries
Thailand
Outcome results
None listed