Background

The present study aimed to examine the effect of magnesium (Mg) supplementation on cisplatin-induced nephrotoxicity (CIN) in pediatric cancer patients.

Methods

The present phase-2, open-label, multicenter, randomized controlled trial enrolled patients aged less than 20 years who were scheduled to receive cisplatin-containing chemotherapy and randomly allocated them at a ratio of 1:1 to a Mg supplementation arm with even-numbered chemotherapy courses (arm AB) or another arm with odd-numbered courses (arm BA). Analysis objects were reconstructed into two groups depending on whether the chemotherapy course had Mg supplementation (group B) or not (group A). The primary outcome was the proportion of chemotherapy courses resulting in elevated serum creatinine per chemotherapy course. The secondary outcomes included efficacies evaluated using other biomarkers and the safety of the Mg supplementation.

Results

Twenty-eight patients were randomly allocated to either group (16 to arm AB and 12 to arm BA). The baseline characteristics of the groups were similar. There was no significant difference in the proportion of courses with increased serum creatinine between the groups (group A: 10% vs. group B: 6%; P = 0.465) nor was any significant difference observed in other biomarkers during any chemotherapy course. The Mg value during chemotherapy was significantly higher in group B than that in group A. No adverse events related to magnesium administration were observed.

Conclusions

The study design, which treated a single chemotherapy course as a study object, failed to detect a statistically significant benefit of Mg supplementation for preventing CIN in pediatric cancer patients.

Trial registration

JRCT (https://jrct.niph.go.jp/) Identifier UMIN000029215 jRCTs031180251. UMIN-CTR (http://www.umin.ac.jp/icdr/index.html) Identifier UMIN000029215.

中文翻译：

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镁补充剂治疗预防顺铂引起的儿童癌症急性肾毒性：一项随机 2 期试验

背景

本研究旨在探讨补充镁 (Mg) 对儿童癌症患者顺铂诱导的肾毒性 (CIN) 的影响。

方法

目前的 2 期、开放标签、多中心、随机对照试验招募了年龄小于 20 岁、计划接受含顺铂化疗的患者，并以 1:1 的比例将他们随机分配到镁补充剂组，其中编号的化疗疗程（AB 组）或奇数疗程的另一组（BA 组）。根据化疗过程中是否补充镁（B组）或不补充镁（A组），将分析对象重建为两组。主要结局是每个化疗疗程导致血清肌酐升高的化疗疗程的比例。次要结果包括使用其他生物标志物评估的疗效以及镁补充剂的安全性。

结果

28 名患者被随机分配至任一组（AB 组 16 名，BA 组 12 名）。各组的基线特征相似。各组之间血清肌酐升高的疗程比例没有显着差异（A 组：10% vs B 组：6%；P  = 0.465），在任何化疗过程中其他生物标志物也没有观察到任何显着差异。 B组化疗期间的Mg值显着高于A组。未观察到与镁给药相关的不良事件。

结论

该研究设计以单一化疗疗程为研究对象，未能检测到补充镁对于预防儿科癌症患者 CIN 具有统计学上的显着益处。

试用注册

JRCT (https://jrct.niph.go.jp/) 标识符 UMIN000029215 jRCTs031180251。 UMIN-CTR (http://www.umin.ac.jp/icdr/index.html) 标识符 UMIN000029215。