Role of NK-1 receptor antagonist for prevention of chemotherapy induced nausea and vomiting in patients receiving highly emetogenic chemotherapy (HEC): An Investigator-initiated, Multicenter, Double blind, Randomized, Placebo controlled, Superiority trial

CI AIIMS0 个研究点目标入组 250 人开始时间: 待定最近更新: 2023年7月25日

试验速览

暂无简介。

•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 (<= 2 mg/dl), SGOT / SGPT (<= 3 X ULN, Bilirubin <2.0 mg/dl)
•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 >=
•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

•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

发起方

CI AIIMS