Effect of domperidone containing antiemetic regimen on the electrical activity of heart in patients with malignancy
Not Applicable
Completed
- Conditions
- Health Condition 1: C00-D49- NeoplasmsHealth Condition 2: C00-D49- Neoplasms
- Registration Number
- CTRI/2018/09/015676
- Lead Sponsor
- Dr Ashwin Kamath
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 36
Inclusion Criteria
1. Will be receiving domperidone, 5-HT3 antagonist and olanzapine containing antiemetic regimen
2. ECOG status <= 2
3. Willing to provide informed consent
Exclusion Criteria
1. Baseline QTc interval > 450 milliseconds
2. History of cardiac arrhythmias
3. A history of additional risk factors for Torsades de Pointes (e.g., heart failure, hypokalemia, family history of long QT syndrome)
4. The use of concomitant medications that prolong the QT/QTc (other than the study drugs)
5. If the investigator is of the opinion that the patient will be unable to complete the study due to any reasons
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from baseline in QT intervalTimepoint: Day 0, 1, 2, 3
- Secondary Outcome Measures
Name Time Method Change from baseline in heart rateTimepoint: Day 0, 1, 2, 3