ABSTRACT
PURPOSE: Evaluating the role of cystone, a polyherbal preparation, in protecting cancer patients against cisplatin-induced nephrotoxicity, and its impact on the cytotoxic activity of cisplatin. METHODS: A prospective open-label randomized controlled trial conducted on 49 cancer patients who received six cycles of 70 mg/m(2) cisplatin-based regimens. The study comprised two groups, a control group (A) in which 28 patients received cisplatin without cystone supplement, and an experimental group (B) in which 21 patients received cisplatin with cystone supplement. Renal function parameters including serum creatinine, creatinine clearance, blood urea, and serum cystatin C were compared between both groups throughout chemotherapy cycles. Patient response to treatment was evaluated in both groups after 3rd and 6th cycles. RESULTS: At the end of the study, mean levels of serum creatinine, blood urea, and serum cystatin C were significantly lower, whereas creatinine clearance was significantly higher in group (B) compared with group (A). In group (B), there was no significant difference between mean levels of renal markers at baseline and after completion of treatment; while significant changes were observed in group (A). Grading of acute kidney injury according to Common Terminology Criteria for Adverse Events revealed significantly better renal status among patients in group (B) "grades 0 and 1 in 76 and 24 % of the patients, respectively" compared with group (A) "grades 0, 1, and 2 in 36, 32, and 32 % of the patients, respectively". Based on Response Evaluation Criteria in Solid Tumors, there was no significant difference between both groups. CONCLUSIONS: Cystone can protect cancer patients from cisplatin nephrotoxicity without interfering with its antitumor activity.