A randomized, open label, parallel group, phase III randomized trial to evaluate the efficacy of Resveratrol-copper in patients receiving 5-Fluorouracil based chemotherapy regimens to reduce grade 3- 5 Muco-cutaneous toxicities. (ReForM study) - Reform Study

Tata Memorial Centre0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年8月21日

试验速览

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•1.Diagnosis of any solid tumour malignant disease.
•2.Patients scheduled to receive 5-FU based chemotherapy regimen.
•3.Age >= 18 years.
•4.ECOG performance status should be 0-2.
•5.Subjects must have normal organ and marrow function as defined below:
•a.Hematologic: Absolute neutrophil count (ANC) >= 1.5 Ã? 109/L, platelet count >= 100 Ã? 109/L, and hemoglobin >= 8 g/dL (may have been transfused).
•b.Hepatic: Total bilirubin level <= 1.5 Ã? the upper limit of normal (ULN) range and AST and ALT levels <= 2.5 Ã? ULN or AST and ALT levels <= 5 x ULN (for subjects with documented metastatic disease to the liver).
•c.Renal: Estimated creatinine clearance >= 30 mL/min according to the Cockcroft-Gault formula.
•6.Negative pregnancy test (serum or urine) done <= 7 days prior to participation, for women of childbearing potential only (per clinician discretion).
•7.Women of reproductive potential who agree to use an appropriate method of birth control throughout their participation in this study due to the teratogenic potential of the therapy utilized in this trial.
•8.Patient willing and able to comply with all study requirements, including treatment, able to be followed up at regular intervals and/or nature of required assessments.
•9.Ability to understand and the willingness to sign a written informed consent document.

•1.Patients with severe cognitive compromise.
•2.Patients with a history of CNS disease (e.g., brain metastases, seizure disorder)
•3.Known hypersensitivity to Resveratrol or copper.
•4.Medical conditions such as uncontrolled infection (including HIV), uncontrolled diabetes mellitus, or cardiac disease, which, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient.
•5.Patients unwilling to participate in the study.
•6.Any previous consumption of R-Cu.
•7.Any active mucocutaneous toxicity from previous therapy of disease which may interfere with the evaluation of chemotoxicity.
•8.Patients who have received any radiation/radiotherapy within the last one year.

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