A study to compare benefits of Olanzapine 5mg over Olanzapine 10mg for prevention of nausea and vomiting caused by anticancer medicines.
Phase 3
- Conditions
- Health Condition 1: C00-D49- Neoplasms
- Registration Number
- CTRI/2024/04/066232
- Lead Sponsor
- Department of Pharmacology and Department of RadioOncology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1-18 years of age or older patients who had not received previous chemotherapy
2-Patients going to receive 1st cycle of highly emetogenic cancer chemotherapy
3-Written informed consent.
4-Able to understand and describe patient-reported outcomes.
Exclusion Criteria
1-History of hypersensitivity or allergy to any of antiemetic drugs we are going to use in study
2-Received any chemotherapy in last 3 weeks.
3-Multiday chemotherapy regimen, concurrent radiotherapy
4-brain metastasis
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method primary outcome- complete response of vomiting in early(0- 24hrs), delayed(24-120 hrs) in both groups <br/ ><br>Secondary outcome- to record different grades of chemotherapy induced nausea and vomiting in all three periodsTimepoint: early(0- 24hrs), delayed(24-120 hrs) and overall period (0-120hrs)
- Secondary Outcome Measures
Name Time Method To record different grades of chemotherapy induced nausea and vomiting (CINV) in all three periods: - Acute (0- 24 hrs), Delayed (24 -120hrs), overall(0-120hrs).Timepoint: early(0- 24hrs), delayed(24-120 hrs) and overall period (0-120hrs)