Aprepitant and Olanzapine in the treatment of vomiting
Phase 3
Completed
- Conditions
- Health Condition 1: null- Breast cancer
- Registration Number
- CTRI/2017/12/010869
- Lead Sponsor
- Mysore medical college ad research institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Histologically confirmed breast cancer.
2. Chemotherapy naive patients.
3. Not complaining of nausea in the past 24
hours prior to initiation of chemotherapy.
4. Renal and liver function tests of the
patients within the normal range
5. Patients with child bearing potential had to
have a negative urine pregnancy test
Exclusion Criteria
1. History of seizure disorder
2. Brain Metastasis
3. Treatment with another antipsychotic agent
such as risperidone, quetiapine, clozapine,
phenothiazine or butyrophenone for 30 days
prior to or during protocol therapy.
4. Hypersensitivity to olanzapine
5. History of cardiac arrhythmia
6. Uncontrolled congestive cardiac failure or
acute myocardial infarction in the previous
6 months
7. History of diabetes mellitus
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To Compare the efficacy of Aprepitant and Olanzapine in the prevention of Chemotherapy Induced Nausea.Timepoint: Day 1 to day 5 from the start of chemotherapy
- Secondary Outcome Measures
Name Time Method To Compare the efficacy of Aprepitant and Olanzapine in the prevention of acute and delayed emesisTimepoint: Day 1 to day 5 from the start of chemotherapy