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Magnesium supplementation therapy to prevent cisplatin-induced acute nephrotoxicity in pediatric cancer: A randomized phase 2 trial
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  • Motohiro Matsui,
  • Atsushi Makimoto,
  • Motoaki Chin,
  • Katsuyoshi Koh,
  • Masako Tomotsune,
  • Tetsuji Kaneko,
  • Yoshihiko Morikawa,
  • Riku Hamada,
  • Yuki Yuza
Motohiro Matsui
Tokyo Toritsu Shoni Sogo Iryo Center

Corresponding Author:motohiro_matsui@tmhp.jp

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Atsushi Makimoto
Tokyo Toritsu Shoni Sogo Iryo Center
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Motoaki Chin
Nihon Daigaku Igakubu Fuzoku Itabashi Byoin
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Katsuyoshi Koh
Saitama Kenritsu Shoni Iryo Center
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Masako Tomotsune
Tokyo Toritsu Shoni Sogo Iryo Center
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Tetsuji Kaneko
Tokyo Toritsu Shoni Sogo Iryo Center
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Yoshihiko Morikawa
Tokyo Toritsu Shoni Sogo Iryo Center
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Riku Hamada
Tokyo Toritsu Shoni Sogo Iryo Center
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Yuki Yuza
Tokyo Toritsu Shoni Sogo Iryo Center
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Abstract

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 II, 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 elevating 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 elevated 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 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.