Health Condition 1: null- Cancer chemotherapy patients with performance status ECOG 1, 2 and 3 Health Condition 2: C00-D49- Neoplasms
Conditions
Interventions
Intervention1: Drug OLANZAPINE 10 MG: Anti emetic prophylaxis with : OLANZAPINE 10 MG ONCE A DAY FOR 3 DAYS FROM DAY 1 OF CHEMOTHERAPY
(+ ONDANSETRON 16 MG ON DAY1 + DEXAMETHASONE 8 MG TWICE A DAY FOR
Sponsors
Sandip Mukhopadhyay
Eligibility
Inclusion 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 3. Acceptable renal function (Serum creatinine = 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Complete response (CR) in the period of day 2 to day 5 (25-120 hours) for delayed emesis will be noted. 2.CR in the overall day 1 to day 5 (0-120 hour period) will be noted. 3.Incidence & severity of sedation during the treatment period. 4.Incidence of emesis in overall five days. 5.Control of nausea from day 1 to day 5 (0-120 hour period) will be noted by using MASCC antiemesis tool (MAT) & CTCAE (Common terminology criteria for adverse events).Timepoint: 5 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Acute emesis and number of CR in first 0-24 hours. 2. Number of patients with complete control (CC) from day 2 to day 5. 3. Use of any rescue medication from day 1 to day 5 4. Adverse drug reactions (ADR)/ ADE will be recorded on day 1, day 3 and day 8. Voluntary disclosures of ADE/ ADRs by the patient at any time will be recorded during this study period. 5. Overall quality of life after chemotherapy will be assessed using the â??FACT G7â?? questionnaire on 8th to 15th day.Timepoint: 5- 15 DAYS | — |
Countries
India
Contacts
Public ContactSandip Mukhopadhyay
Burdwan Medical College & Hospital
Outcome results
None listed