Efficacy and safety of oral magnesium supplementation in reducing febrile neutropenia episodes in children with solid tumors treated with cisplatin-based chemotherapy: randomized clinical trial
Castelán-Martínez OD, Palomo-Colli MA, Barrios-López VE, Silva-Jivaja KM, Juárez-Villegas LE, Castañeda-Hernández G, Sánchez-Rodríguez MA
Cancer chemotherapy and pharmacology · 2 citas
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Eventos clínicos como enfermedad o muerte
Quién lo pagó
- Financiación
- Financiación independiente
- Universidad u hospital
- Dirección General de Asuntos del Personal Académico, Universidad Nacional Autónoma de México
- Subvenciones
- Dirección General de Asuntos del Personal Académico, Universidad Nacional Autónoma de México (PAPIIT-IA207417)
Según 1 financiador declarado.
Publicación
- Publicado
- 2020-10-08 · Cancer Chemother Pharmacol · vol. 86 · número 5 · págs. 673–679
- Editorial
- Springer Science+Business Media
- Citado
- 3 citas · más que el 42% de estudios similares · 0.1× el promedio de su campo
- Referencias
- 27 trabajos
- Acceso
- De pago
- Áreas de investigación
- Neutropenia and Cancer Infections · Magnesium in Health and Disease · Chemotherapy-induced organ toxicity mitigation
- Palabras clave
- oral magnesium supplementation, febrile neutropenia, cisplatin-based chemotherapy, pediatric solid tumors, hypomagnesemia, septic shock, chemotherapy-induced neutropenia, children
- MeSH
- humans, neoplasms, cisplatin, magnesium, filgrastim, antineoplastic combined chemotherapy protocols, administration, oral, follow-up studies, dietary supplements, adolescent, child, mexico, male, febrile neutropenia
7 autores
- Osvaldo D. Castelán-Martínez🇲🇽 · autor de correspondenciaUniversidad Nacional Autónoma de México
- Miguel Ángel Palomo-Collí🇲🇽Hospital Infantil de México Federico Gómez
- Victoria E. Barrios-López🇲🇽Hospital Infantil de México Federico Gómez; Instituto Politécnico Nacional; Centro de Investigación y de Estudios Avanzados del Instituto Politécnico Nacional
- Karla M. Silva-Jivaja🇲🇽Universidad Nacional Autónoma de México
- Luis Juárez‐Villegas🇲🇽Hospital Infantil de México Federico Gómez
- Gilberto Castañeda‐Hernández🇲🇽Instituto Politécnico Nacional; Centro de Investigación y de Estudios Avanzados del Instituto Politécnico Nacional
- Martha A. Sánchez-Rodrı́guez🇲🇽Universidad Nacional Autónoma de México
Resumen
El texto original del estudio, en el idioma en que se publicó.
Purpose
Hypomagnesemia has been associated with febrile neutropenia (FN) in pediatric patients receiving cisplatin-based chemotherapy (CDDPBC). The primary aim was to determine whether oral magnesium supplementation reduces FN episodes in pediatric patients with solid tumors treated with CDDPBC.
Method
This randomized clinical trial, with open-label, single-center, parallel group and superiority design was conducted in Hospital Infantil de Mexico Federico Gomez at Mexico City. Children ≥ 9 years with solid tumors that were to receive a CDDPBC cycle were invited to participate. Each chemotherapy cycle with CDDPBC was randomly assigned to receive oral magnesium supplementation (250 mg/day) or not receive magnesium supplementation (control group). Efficacy was determined by relative risks (RR) with 95% confidence intervals (95% CI) as well as with numbers needed to treat (NNT). Active surveillance was conducted to assess safety in both groups. Analyses were carried out by intention to treat. ClinicalTrials.gov number NCT03449693.
Results
One hundred and one chemotherapy cycles with CDDPBC were analyzed (50 in the magnesium supplement arm and 51 in control group). Baseline clinical characteristics were similar comparing both groups. Oral magnesium supplementation reduces FN episodes compared to control group [RR 0.53, (95% CI 0.32-0.89), NNT = 4]. In the supplemented group, patients had fewer episodes of septic shock secondary to FN [RR 0.43, (95% CI 0.02-0.94), NNT = 6] and FN appeared on average 5 days later (p = 0.031). Hypomagnesemia episodes and adverse events were similar across both groups.
Conclusion
Oral supplementation with magnesium reduces FN episodes neutropenia in pediatric patients with solid tumors treated with CDDPBC.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.
Confianza de la comunidad
Cargando…
¿Cuánto confías en los hallazgos de este estudio?
Comentarios
¿Algo está mal aquí?
Señala este estudio si su información, etiquetas o financiación parecen incorrectas. Un editor revisa cada señalamiento.
Información educativa sobre investigación publicada. No es consejo médico ni una recomendación para empezar o dejar nada.