Trials / Unknown
UnknownNCT03876938
Olanzapine Versus Aprepitant Based Antiemetic Regimen for High Emetic Chemotherapy
Randomized, Placebo-controlled Trial of Olanzapine Versus Aprepitant Plus Ondansetron and Dexamethasone as Antiemetic Prophylaxis in Patients Receiving High Emetic Chemotherapy
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 147 (estimated)
- Sponsor
- Mahidol University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | aprepitant | 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 |
| DRUG | olanzapine 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 |
| DRUG | olanzapine 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 |
Timeline
- Start date
- 2019-03-01
- Primary completion
- 2020-08-01
- Completion
- 2020-12-01
- First posted
- 2019-03-15
- Last updated
- 2019-03-15
Locations
2 sites across 1 country: Thailand
Source: ClinicalTrials.gov record NCT03876938. Inclusion in this directory is not an endorsement.