Abstract
Abstract Purpose Cisplatin is a cost effective widely used antineoplastic drug to treat a number of solid tumors. The major dose-limiting toxicity is nephrotoxicity. Cystone is one of drugs that have been tested to reduce the incidence of cisplatin-induced acute kidney injury (CIAKI). This study aimed to investigate the protective effect of Cystone against CIAKI in larger number of patients relative to previously conducted pilot studies . Methods A prospective phase II, open-label randomized controlled study was conducted in patients receiving cisplatin-based chemotherapy in Ain Shams University Hospitals, using cystone tablet (manufactured by the Himalayan Pharmaceutical Company, India) administered as two pills every 8 hours continuously through course of chemotherapy starting from the day before receiving chemotherapy. A total of 99 patients were randomized between the control and cystone arms. The primary endpoint was the incidence of AKI according to Common Terminology Criteria Adverse Events (CTCAE) in each treatment arm. Secondary endpoints include need to dose modification between both arms. Results There was clinical difference in the incidence of CIAKI any grade between the two arms (12% in cystone arm vs 34 % in control arm P = 0.4. Need to dose modification is 10.4% vs 12 % (P = 0.8). There was a statistically significant difference between the two arms as regards the difference between values (mean) of serum creatinine and creatinine clearance values initially and at the end of treatment favoring drop of renal functions in control group (P = 0.000 and 0.003) respectively. Conclusion Our study did not demonstrate clearly a protective role of cystone in decreasing the incidence of CIAKI in patients receiving cisplatin based chemotherapy. However, drop of renal function in control arm with comparison to study arm may give an indication to further study cystone in different doses to assess its protective role against CIAKI.
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