CTRI/2021/07/034813
Completed
Phase 2
A pilot study to evaluate the feasibility and efficacy of dexamethasone free anti emetic regimen in patients receiving highly emetogenic chemotherapy
CI AIIMS0 sites101 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- CI AIIMS
- Enrollment
- 101
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •a. Diagnosis of malignancy
- •b. No prior chemotherapy and radiation therapy (RT)
- •c. Age of ââ?°Â¥ 18 ââ?¬â?? up to 70 years
- •d. ECOG Performance status (0\-2\)
- •e. Complete hemogram (ANC ââ?°Â¥1000/m3, TLC ââ?°Â¥3000/m3, Platelets ââ?°Â¥ 1,00,000/m3\), Creatinine (ââ?°Â¤ 2 mg/dl), SGOT / SGPT (ââ?°Â¤ 3 X ULN, Bilirubin \<2\.0 mg/dl)
- •f. First cycle of highly emetogenic chemotherapy defined as
- •1\. Cisplatin at dose ââ?°Â¥70mg/m2 with or without other agents
- •2\. Single agent Anthracycline (Doxorubicin ââ?°Â¥ 60mg/m2, Epirubicin ââ?°Â¥ 90mg/m2\)
- •3\. AC (Doxorubicin ââ?°Â¥ 60mg/m2, Epirubicin ââ?°Â¥ 90mg/m2 \+ Cyclophosphamide ââ?°Â¥
- •4\. Dacarbazine based therapy (ABVD)
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 ââ?¬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. Started on opioids in last 48 hours
- •l. Female who are pregnant, lactating
Outcomes
Primary Outcomes
Not specified
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