Efficacy and Safety of Short Intravenous Hydration for Preventing Nephrotoxicity From High-Dose Cisplatin: A Randomized, Open-Label, Phase II Trial.

Abstract

Purpose: The use of short hydration (SH) to prevent cisplatin-induced nephrotoxicity lacks substantive prospective evaluation. The aim of this study was to evaluate the safety and efficacy of SH, including those with head and neck cancer (HNC) who are at higher risks of mucositis that causes diminished oral intake.

Methods: This phase II randomized noncomparative trial included patients with cancer who were scheduled to receive high-dose cisplatin (≥60 mg/m²) in combination with another chemotherapy or concurrently with radiotherapy. Patients were randomly assigned to receive either the SH or conventional hydration (CH) protocol. The primary end point was the proportion of patients with increased serum creatinine (SCr) after undergoing SH. Secondary end points included the severity of SCr elevation, adverse events, cisplatin modification as a result of nephrotoxicity, duration of hospital stay, quality of life (QoL), and cost.

Results: Among 100 enrolled patients, 64 and 36 patients underwent the SH and CH protocols, respectively. The median duration of chemotherapy infusion and intravenous hydration were 5.79 and 27.58 hours with SH and CH, respectively. A total of 32.8% and 33.3% of the SH and CH groups, respectively, experienced SCr elevation. Grade 2 SCr elevations were rarely observed in both groups (1.6% in SH, 2.8% in CH). Rate of cisplatin modification was similar between the two groups. Out of 82 patients with HNC, the rate of SCr elevation was comparable for both hydration protocols. The QoL scores were meaningfully higher in the SH group during the second cycle of cisplatin, although the overall direct medical costs were similar.

Conclusion: The SH protocol is feasible and safe, with a remarkably reduced duration of administration. Thus, SH can be an alternative to CH in the prevention of cisplatin-related nephrotoxicity.