Health Condition 1: C00-D49- Neoplasms
Conditions
Interventions
Intervention1: Fosaprepitant: -HT3 Antagonist (Ondansetron) +
Dexamethasone + Olanzapine + Fosaprepitant (100ml Normal saline)
Intervention2: Fosaprepitant: Inj. Ondansetron, 16mg, IVP, Day 1 +
Sponsors
NCI AIIMS
Eligibility
Inclusion criteria
Inclusion criteria: a. Diagnosis of malignancy b. No prior chemotherapy and radiation therapy (RT) c. Age of 18 years or more, up to 70 years d. ECOG Performance status (0-2) e. Complete hemogram (ANC >=1000/m3, TLC >=3000/m3, Platelets >= 1,00,000/m3), Creatinine ( f. First cycle of highly emetogenic chemotherapy defined as 1. Cisplatin at dose >=70mg/m2 with or without other agents 2. Single agent Anthracycline (Doxorubicin >= 60mg/m2, Epirubicin >= 90mg/m2) 3. AC (Doxorubicin >= 60mg/m2, Epirubicin >= 90mg/m2 + Cyclophosphamide >= 600mg/m2) 4. Dacarbazine based therapy (ABVD) g. Willing to give written informed consent for the study participation h. Able to read and write in English or Hindi
Exclusion criteria
Exclusion criteria: a. Patient receiving concurrent quinolone, amifostine, warfarin, OCP, psychiatric drugs, Benzodiazepines, Anti-convulsant drugs, strong or moderate CYP3A4 inhibitors (diltiazem, Ketoconazole), strong CYP3A4 inducers (rifampicin), pimozide, cisapride, terfenadine, astemizole, CYP1A2 inhibitors (ciprofloxacin, fluvoxamine) b. History of chronic alcoholism c. Hypersensitivity to any of the drugs used in the study {Olanzapine, NK-1 antagonist (Fosaprepitant), 5-HT3 antagonist â?? Ondansetron} d. On systemic steroids, active smoker e. History of any uncontrolled systemic disease including hypertension, thyroid, CNS, renal, CHF and MI in last 6 months and requiring hemodialysis, psychiatric disorder f. Symptomatic Brain metastasis / Carcinomatous Meningitis g. History of nausea and vomiting in 24 hours prior to first dose of chemotherapy i. Use of anti-emetic drugs (5-HT3 Antagonist) in last 48 hours j. Ascites requiring therapeutic paracentesis in last 2 weeks, Intestinal obstruction k. Started on opioids in last 48 hours l. Female who are pregnant, lactating m. Diabetic patient on oral hypoglycemic drugs or Insulin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the added benefit of NK-1 receptor antagonist to the olanzapine based anti-emetic regimen in patient receiving HEC, in term of rate of complete response (CR) during the overall period (0-120 hours)Timepoint: To evaluate the added benefit of NK-1 receptor antagonist to the olanzapine based anti-emetic regimen in patient receiving HEC, in term of rate of complete response (CR) during the overall period (0-120 hours) | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the rate of complete response in two arms during the acute period (AP) and delayed period (DP) To compare the rate of nausea and no clinically significant nausea control in two arms during the AP, DP and OP To compare the rate of total control and complete control in two arms during the AP and OP Toxicity pattern and Time to treatment failure The severity of undesired sedation and increased appetite Timepoint: 2 year | — |
Countries
India
Contacts
Public ContactAkash Kumar
NCI AIIMS
Outcome results
None listed