Prevention of cisplatin nephrotoxicity (CN) in head and neck cancer patients receiving concurrent chemoradiation (CCRT) by adding oral rehydration solution (ORS) to short hydration regimen: a randomized open-label controlled trial.

Aungsumal Maisrikrod, Siwat Sakdejayont, Jakkapan Rongmuang, Chirawadee Sathitruangsak, Patrapim Sunpaweravong, Arunee Dechaphunkul

The Thai Cancer, 2020, 31.63.018

Abstract

Backgrond: CN remains a frequent occurrence despite receiving standard fluid hydration, particularly for head and neck cancer patients undergoing CCRT. We aimed to investigate whether adding ORS to short hydration regimen can reduce CN.

Method: We conducted a randomized open-label controlled trial in patients with head and neck cancer receiving CCRT with 3-weekly cisplatin (≥ 50 mg/m2). Eligible patients were randomly assigned to receive short hydration regimen (2000 mL of normal saline on day 1) alone or in combination with 2000 mL of ORS on days -1, 2 and 3 of each cycle. The primary end point was the incidence of ≥ gr 1 creatinine (Cr) elevation on day 8. Key secondary end points were Cr elevation on day 90, and safety. The planned sample size was 160 (80 patients each arm).

Results: Thirty-nine patients in ORS group and 41 patients in control group (50% of planned sample size) were enrolled. Baseline characteristics were balanced between the two groups, except more patients in ORS group underwent surgery (30.8% vs. 22%), and had less feeding tube prophylaxis (79.5% vs. 85.4%), although there were not statistically significant. The mean dose of cisplatin on day 1 was significantly higher in ORS group (90 mg/m2 vs. 84.4 mg/m2, p=0.01). There were no difference of volume of total fluid intake and toxicities between the two groups. The incidence of ≥ gr 1 creatinine (Cr) elevation on day 8 was 87.2% in the ORS group, as compared with 90.2% in the control group (p=0.734). Less percentage of patients in ORS group developed ≥ gr 1 Cr elevation on the subsequent visits; 66.7% vs. 73.2% on day 15, 66.7% vs. 70.7% on day 22, and 66.7% vs. 73.3% on day 90, although there were not statistically significant.

Conclusion: Although our interim analysis showed no significant difference of CN between the groups, there was a trend that addition of ORS might prevent acute and chronic kidney injury secondary to cisplatin. The completed enrollment is warranted to confirm this early findings.