CTRI/2020/02/023589
Recruiting
未知
COMPARATIVE STUDY OF LOW DOSE VERSUS STANDARD DOSE OF OLANZAPINE AS AN ADD-ON IN CONTROL OF CHEMOTHERAPY INDUCED NAUSEA AND VOMITING IN PATIENTS RECEIVING MODERATELY EMETOGENIC CHEMOTHERAPY - LONCIV
Sandip Mukhopadhyay0 sites100 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Sandip Mukhopadhyay
- Enrollment
- 100
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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