Old drug in new dose: Olanzapine in chemotherapy induced nausea & vomiting, does dose matters?
- Conditions
- Health Condition 1: null- Cancer chemotherapy patients with performance status ECOG 1, 2 and 3Health Condition 2: C00-D49- Neoplasms
- Registration Number
- CTRI/2020/02/023589
- Lead Sponsor
- Sandip Mukhopadhyay
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 100
1.Chemotherapy patients with age >= 18 years up to 80 years from both genders with histologically proven malignancy who have been offered high or moderately emetogenic chemotherapy.
2.Acceptable hepatic function (serum bilirubin < 3mg/dl and transaminase < 3X upper limit of normal).
3.Acceptable renal function (Serum creatinine < 2mg/dl and/or Creatinine clearance >= 50ml/min).
4.No nausea in the previous 24 hours of starting the therapy.
5.Absolute neutrophil count >1500/ dl
6.Education level at least 5th standard.
7.Life expectancy 4 months or more.
1.CNS disorders e.g. seizure, unstable brain metastasis.
2.Serious cardiac arrhythmia or dysfunction, congestive heart failure (CHF), recent myocardial infarction (MI).
3.Any uncontrolled severe concurrent illness or uncontrolled diabetes.
4.Gastric outlet obstruction, intestinal obstruction.
5.Vomiting within the last 24 hours before study drug administration.
6.Hypersensitivity to any of the study drugs.
7.Patients who received any cancer chemotherapy within the previous 3 weeks.
8.Patients who received any anti-emetic, corticosteroid or any other drug that may influence the study within previous 24 hours.
9. Treatment with any antipsychotic drugs in previous 30 days of start of study,
10.Use of any other investigational drug and participation in any other study within 30 days of study enrollment.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method