Throtoxicity: A pilot, randomized, double-blinded, placebo-controlled clinical trial.

Cisplatin-induced nephrotoxicity (CIN) is a major dose-limiting factor in cisplatin use for the management of human cancers. This study was designed to evaluate the effect of melatonin on CIN as the first clinical trial in humans. This pilot, randomized, double-blinded, placebo-controlled clinical trial was conducted with cancer patients. Participants were randomly assigned to receive either 20 mg/day oral melatonin or placebo from 24 to 48 hours before cisplatin therapy. Urine samples were collected at 0, 6 and 24 h following cisplatin infusion to evaluate urinary neutrophil gelatinase-associated lipocalin (NGAL), kidney injury molecule-1 (KIM-1), and creatinine. Serum creatinine (SCr) levels were assessed at baseline and 72 h after cisplatin administration. Fifty-five patients were randomly assigned to receive either melatonin (n = 25) or placebo (n = 30), where 3 (7.5 %) versus 9 (21.4 %) acute kidney injury (AKI) episodes were reported in each group respectively. Although urinary biomarkers increased in both groups, the magnitude of the increase was smaller in the melatonin group compared to placebo. In addition, differences of urine KIM-1/creatinine ratio at 6 h and 24 h from baseline were significantly lower in the melatonin group (2.37(−71.16 to 63.70) ng/mg and −1.45(−80.28 to 48.76) ng/mg) compared to placebo (3.83(−11.19 to 37.05) ng/mg and 0.38(−5.42 to 70.00) ng/mg). This study showed that the number of AKI episodes in patients who received melatonin was lower compared to the placebo group, although it was not found to be statistically significant due to the small sample size. Moreover, melatonin administration in cisplatin recipients reduced tubular kidney injury, evidenced by less increase in KIM-1/creatinine and NGAL/creatinine ratios. [ABSTRACT FROM AUTHOR]