Thalidomide for the prevention of chemotherapy-induced nausea andvomiting (CINV) in the second cycle among patients receiving HighlyEmetogenic Chemotherapy (HEC) and having any nausea in the first cycle:A Randomized, Double-blind, Placebo-controlled trial

Jawaharlal Institute of Postgraduate Medical Education Research0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年10月16日

试验速览

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•1. Age =18 years
•2. Patients receiving first-line therapy with one of the below HEC regimens:
•? Anthracycline/Cyclophosphamide combination
•? Regimens with Cisplatin > 50 mg /m2
•? ABVD regimen
•3. Patients must provide written informed consent (including consent for telephonic conversation/questionnaire both in the current and next cycle of chemotherapy).
•4. ECOG (Eastern Cooperative Oncology Group) performance status of 0, 1, and 2
•at the time of enrolment in the study
•5. Adequate blood counts and organ functions:
•? ANC: > 1500/cumm
•? Total Bilirubin= 1.5 x ULN
•? AST (SGOT) = 3 x ULN
•? ALT (SGPT) = 3 x ULN
•? Serum creatinine = 2 mg/dL or measured creatinine clearance = 40
•mL/min according to Cockcroft-Gault formula
•6. Nausea/Vomiting of any grade in the acute/delayed period of first chemotherapy cycle.
•7. Receiving the same chemotherapy without dose modifications in the second cycle.
•8. Negative serum/urine pregnancy test in women of childbearing potential
•(WOCBP) within past 7 days of enrollment and willing to adapt childbirth
•control throughout the study period.

•1. Nausea/vomiting in the past 24 hours (prior to initial enrolment and prior to 2nd HEC cycle).
•2. The following malignancies will be excluded as they will cause GI symptoms: GI/ Hepato pancreaticobiliary malignancies, ovarian cancers
•3. Severe neurocognitive impairment.
•4. Known history of central nervous system organic disorder (e.g., Brain metastasis/malignancy, raised ICT)
•5. Known psychiatric disorder
•6. Pre-existing > grade 2 peripheral neuropathy
•7. Human Immunodeficiency Virus (HIV) infection/and or on anti-retroviral therapy and/ or HCV infection (patients who are anti-HCV positive but have been treated and have undetectable viral load would be permitted to be part of the study).
•8. Active Hepatitis B infection (in patients who are Hepatitis B carriers, the markers of active infection such as HBeAg and HBV DNA titers must be negative, and patients would be continued on appropriate prophylaxis with antivirals throughout the study).
•9. Concurrent radiotherapy
•10. Regular alcohol intake (3 or more drinks equivalent of 45 ml of liquor per week)
•11. No known hypersensitivity to the study agents
•12. No known cardiac arrhythmia, uncontrolled CHF, or acute MI within the last 6 months
•13. No history of uncontrolled DM

发起方

Jawaharlal Institute of Postgraduate Medical Education Research