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Aprepitant and Olanzapine in the treatment of vomiting

A comparative study of Aprepitant and Olanzapine in the prevention of chemotherapy induced nausea and vomiting in carcinoma of breast patients.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/12/010869
Enrollment
122
Registered
2017-12-13
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Breast cancer

Interventions

Intervention1: Tablet Olanzapine 10mg per orally day 1 to 3: This drug is given from the day of chemotherapy up to day 3 in breast cancer patients receiving doxorubicin 60mg/m2 and cyclophosphamide 60

Sponsors

Mysore medical college ad research institute
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

India

Contacts

Public ContactDr Akshya

Mysore medical college and research institute

dal_muk1@hotmail.com9886873788

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026