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

Autor: Siwat Sakdejayont, Chirawadee Sathitruangsak, Aungsumal Maisrikrod, Jakkapan Rongmuang, Arunee Dechaphunkul, Patrapim Sunpaweravong
Rok vydání: 2020
Předmět:
Zdroj: Journal of Clinical Oncology. 38:e18560-e18560
ISSN: 1527-7755
0732-183X
DOI: 10.1200/jco.2020.38.15_suppl.e18560
Popis: e18560 Background: 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. Methods: We conducted a randomized open-label controlled trial in patients with head and neck cancer receiving CCRT with 3-weekly cisplatin (≥ 60 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. All patients were instructed to drink at least 2000 mL of fluid. The primary end point was the incidence of ≥ gr 1 creatinine (Cr) elevation on day 8. The planned sample size was 160 (80 patients each arm). Results: Thirty-five patients in ORS group and 34 patients in control group (43% of planned sample size) were enrolled. Baseline characteristics were balanced between the two groups, except more patients in ORS group underwent surgery (35.3% vs. 22.9%), and had less feeding tube prophylaxis (76.5% vs. 88.6%), although there were not statistically significant. The mean dose of cisplatin on day 1 was significantly higher in ORS group (91.2 mg/m2 vs. 85.1 mg/m2, p=0.01). There was no difference of volume of total fluid intake and toxicities between the two groups. Less percentage of patients in ORS group developed ≥ gr 1 Cr elevation as shown in the Table, although there were not statistically significant. Conclusions: 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. Clinical trial information: TCTR20200207005 . [Table: see text]
Databáze: OpenAIRE
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