Magnesium supplementation therapy to prevent cisplatin-induced acute nephrotoxicity in pediatric cancer: A protocol for a randomized phase 2 trial
Makimoto A, Matsui M, Chin M, Koh K, Tomotsune M, Kaneko T, Morikawa Y, Yuza Y
Contemporary clinical trials communications · 6 citas
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (clasificado por nuestro filtro de IA)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiación independiente
- Gobierno
- Tokyo Metropolitan Government
- Gobierno
- Clinical Research Fund of the Tokyo Metropolitan Government, Japan
Según 2 financiadores declarados y la declaración de financiación del texto completo.
Publicación
- Publicado
- 2019-08-22 · Contemp Clin Trials Commun · vol. 16 · pág. 100440
- Editorial
- Elsevier BV
- Citado
- 9 citas · más que el 66% de estudios similares · 0.6× el promedio de su campo
- Referencias
- 22 trabajos
- Acceso
- Acceso abierto (revista) · CC-BY-NC-ND
- Áreas de investigación
- Chemotherapy-induced organ toxicity mitigation · Chemotherapy-induced cardiotoxicity and mitigation · Kidney Stones and Urolithiasis Treatments
- Palabras clave
- Nephrotoxicity, Medicine, Cisplatin, Chemotherapy, Creatinine, Renal function, Clinical endpoint, Urology, Internal medicine, Randomized controlled trial, Cystatin C, Clinical trial, Oncology, Gastroenterology, Kidney
8 autores
- Atsushi Makimoto🇯🇵 · autor de correspondenciaTokyo Metropolitan Children's Medical Center
- Motohiro Matsui🇯🇵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
- Yuki Yuza🇯🇵Tokyo Metropolitan Children's Medical Center
Resumen
El texto original del estudio, en el idioma en que se publicó.
Although cisplatin is one of the most effective agents against various pediatric cancers, it is sometimes difficult to manage due to its dose-limiting nephrotoxicity. Magnesium sulfate (Mg) showed a kidney-protective effect against cisplatin-induced nephrotoxicity (CIN) by regulating renal platinum accumulation both in vitro and in vivo, and the body of clinical data demonstrating the efficacy of this drug in adult cancer patients is increasing.In this open, multicenter, phase-2, randomized trial, patients under age 18 years who are scheduled to receive cisplatin-containing chemotherapy will be enrolled and randomly allocated either to an Mg supplementation arm in even-numbered chemotherapy courses (arm AB) or to another arm in odd-numbered courses (arm BA), with a 1:1 allocation. Analysis objects will be reconstructed into two groups depending on whether the chemotherapy course has Mg supplementation (group B) or not (group A). The primary endpoint is the proportion of chemotherapy courses resulting in elevated serum creatinine equal to or greater than 50% of the prechemotherapy value. For the secondary endpoints, various parameters for measuring kidney function, such as serum cystatin-C, B2M, L-FABP, NGAL, and urinary NAG in the two groups will be compared. A sample size based on alpha = 5% and 80% power requires at least 40 samples per group (ideally, 60 samples per group).If Mg demonstrates efficacy, a phase-3 study to confirm the prophylactic effect of Mg supplementation in both acute and chronic CIN will be developed using novel and better biomarkers.
Trial registration
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 (CC BY-NC-ND).
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