Magnesium supplementation therapy to prevent cisplatin-induced acute nephrotoxicity in pediatric cancer: a randomized phase-2 trial
Matsui M, Makimoto A, Chin M, Koh K, Tomotsune M, Kaneko T, Morikawa Y, Hamada R, Yuza Y
International journal of clinical oncology · 2 citas
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiación independiente
- Universidad u hospital
- Jikei University School of Medicine
- Organización sin fines de lucro
- Children's Cancer Association of Japan
- Universidad u hospital
- Tokyo Metropolitan Hospital
- Organización sin fines de lucro
- Children's Cancer Association of Japan
Según 4 financiadores declarados.
Publicación
- Publicado
- 2024-04-02 · Int J Clin Oncol · vol. 29 · número 5 · págs. 629–637
- Editorial
- Springer Science+Business Media
- Citado
- 2 citas · más que el 63% de estudios similares · 0.5× el promedio de su campo
- Referencias
- 22 trabajos
- Acceso
- Acceso abierto (copia en repositorio) · CC-BY
- Áreas de investigación
- Chemotherapy-induced organ toxicity mitigation · Acute Kidney Injury Research · Metal complexes synthesis and properties
- Palabras clave
- magnesium supplementation, cisplatin, nephrotoxicity, acute kidney injury, childhood cancer, chemotherapy toxicity, serum creatinine
- MeSH
- humans, neoplasms, cisplatin, magnesium, creatinine, antineoplastic agents, dietary supplements, adolescent, child, child, preschool, female, male, young adult, acute kidney injury
9 autores
- Motohiro Matsui🇯🇵 · autor de correspondenciaJikei University School of Medicine; Tokyo Metropolitan Children's Medical Center
- Atsushi Makimoto🇯🇵Tokyo Metropolitan Children's Medical Center
- Motoaki Chin🇯🇵Nihon University
- Katsuyoshi Koh🇯🇵Saitama Children's Medical Center
- Masako Tomotsune🇯🇵Tokyo Metropolitan Children's Medical Center
- Tetsuji Kaneko🇯🇵Tokyo Metropolitan Children's Medical Center
- Yoshihiko Morikawa🇯🇵Tokyo Metropolitan Children's Medical Center
- Riku Hamada🇯🇵Tokyo Metropolitan Children's Medical Center
- Yuki Yuza🇯🇵Tokyo Metropolitan Children's Medical Center
Resumen
El texto original del estudio, en el idioma en que se publicó.
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.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.
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