Clinical trial · Interventional
Efficacy of Oral Supplementation With Magnesium to Reduce Febrile Neutropenia
Efficacy of Oral Supplementation With Magnesium to Reduce Febrile Neutropenia in Pediatric Oncology Patients Treated With Cisplatin-Based Chemotherapy: Randomized Clinical Trial
NCT03449693CI-TRIAL-00031931unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Clinical Trial. Open label. Parallel Groups. The purpose of the study is to determine the efficacy of oral supplementation with magnesium oxide to reduce febrile neutropenia episodes in pediatric oncology patients treated with cisplatin-based chemotherapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Febrile Neutropenia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Magnesium Oxide Supplement | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Magnesium Oxide Supplement
- description
- Magnesium Oxide 250 mg tablet, daily for 30 days.
- interventionNames
- Dietary Supplement: Magnesium Oxide Supplement
- type
- NO_INTERVENTION
- label
- No Supplement
- description
- No Intervention
Primary outcomes (1)
- measure
- Febrile Neutropenia
- timeFrame
- After randomization until day 30
- description
- Unique temperature \>38.3°C or sustained temperature \>38°C over the course of an hour, and a total count of neutrophils \<1000 cells/mm3.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 9 Years
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Pediatric patients \> 9 years old * Pediatric patients with solid tumors treated with cisplatin-based chemotherapy * Signing of Informed Consent from the parents * Signing of Informed Assent from the children Non-inclusion Criteria: * Patients whose parents do not sign the Informed Consent * Patients with magnesium losing tubulopathy * Patients with hypomagnesemia previous to the cisplatin-based chemotherapy Exclusion Criteria: \- Patients whose parents retire the Informed Consent
References
Publications (11)
- BACKGROUNDFreifeld AG, Pizzo PA. The outpatient management of febrile neutropenia in cancer patients. Oncology (Williston Park). 1996 Apr;10(4):599-606, 611-2; discussion 615-6. PMID 8723296
- BACKGROUNDCastagnola E, Paola D, Giacchino R, Rossi R, Viscoli C. Economic aspects of empiric antibiotic therapy for febrile neutropenia in children with cancer. Support Care Cancer. 1998 Nov;6(6):524-8. doi: 10.1007/s005200050208. PMID 9833301
- BACKGROUNDMueller EL, Sabbatini A, Gebremariam A, Mody R, Sung L, Macy ML. Why pediatric patients with cancer visit the emergency department: United States, 2006-2010. Pediatr Blood Cancer. 2015 Mar;62(3):490-5. doi: 10.1002/pbc.25288. Epub 2014 Oct 24. PMID 25345994
- BACKGROUNDKlaassen RJ, Goodman TR, Pham B, Doyle JJ. "Low-risk" prediction rule for pediatric oncology patients presenting with fever and neutropenia. J Clin Oncol. 2000 Mar;18(5):1012-9. doi: 10.1200/JCO.2000.18.5.1012. PMID 10694551
- BACKGROUNDCastelan-Martinez OD, Rodriguez-Islas F, Vargas-Neri JL, Palomo-Colli MA, Lopez-Aguilar E, Clark P, Castaneda-Hernandez G, Rivas-Ruiz R. Risk Factors for Febrile Neutropenia in Children With Solid Tumors Treated With Cisplatin-based Chemotherapy. J Pediatr Hematol Oncol. 2016 Apr;38(3):191-6. doi: 10.1097/MPH.0000000000000515. PMID 26907640
- BACKGROUNDLajer H, Daugaard G. Cisplatin and hypomagnesemia. Cancer Treat Rev. 1999 Feb;25(1):47-58. doi: 10.1053/ctrv.1999.0097. PMID 10212589
- BACKGROUNDKnijnenburg SL, Mulder RL, Schouten-Van Meeteren AY, Bokenkamp A, Blufpand H, van Dulmen-den Broeder E, Veening MA, Kremer LC, Jaspers MW. Early and late renal adverse effects after potentially nephrotoxic treatment for childhood cancer. Cochrane Database Syst Rev. 2013 Oct 8;(10):CD008944. doi: 10.1002/14651858.CD008944.pub2.