Antiemetic for Highly Emetogenic Chemotherapy
Conditions
Brief summary
Aprepitant and olanzapine have been recommended for emesis prevention from highly emetogenic chemotherapy. We hypothesized that olanzapine may lead to less nausea compared to aprepitant based on previous study. However, data of combination of olanzapine and ondansetron is scarce.
Detailed description
Aprepitant and olanzapine have been recommended for emesis prevention from highly emetogenic chemotherapy. We hypothesized that olanzapine may lead to less nausea compared to aprepitant based on previous study. However, data on efficacy and adverse effects of combination of olanzapine and ondansetron which is only serotonin antagonist in Thai national essential drug list, is scarce. Also, we aims to assess the efficacy of olanzapine dosage of 5 mg which is more commonly used in Thai patients.
Interventions
DRUGaprepitant
aprepitant 125 mg orally, dexamethasone 12 mg iv, ondansetron 8 mg iv before chemotherapy aprepitant 80 mg orally D2-4, dexamethasone 8 mg/day orally D2-4
DRUGolanzapine 10 mg
olanzapine 10 mg orally, dexamethasone 12 mg iv, ondansetron 8 mg iv before chemotherapy olanzapine 10 mg orally D2-4, dexamethasone 8 mg/day orally D2-4
DRUGolanzapine 5 mg
olanzapine 5 mg orally, dexamethasone 12 mg iv, ondansetron 8 mg iv before chemotherapy olanzapine 5 mg orally D2-4, dexamethasone 8 mg/day orally D2-4
Sponsors
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* pathologically proved of solid malignancy * receive first cycle of cisplatin \>= 50 mg/m2 or cyclophosphamide/doxorubicin
Exclusion criteria
* pregnancy * patients with episode of vomiting within 24 hours before starting chemotherapy * uncontrolled brain/ CNS metastasis * gut obstruction * receive combination of moderate or high emetogenic chemotherapy during Day 2-5 * Known allergy to ondansetron, olanzapine, aprepitant or dexamethasone * currently receive olanzapine with other indication and plan to continue the drug
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| no nausea rate | Days 1-5 of chemotherapy | proportion of patients report no nausea |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| complete remission | Days 1-5 of chemotherapy | no episode of vomiting |
| >= grade 3 vomiting | Days 1-5 of chemotherapy | higher than grade 3 vomiting |
Countries
Thailand
Contacts
Primary ContactSuthinee Ithimakin, MD
Outcome results
None listed