Status:
UNKNOWN
Efficacy of Oral Supplementation With Magnesium to Reduce Febrile Neutropenia
Lead Sponsor:
Universidad Nacional Autonoma de Mexico
Collaborating Sponsors:
Hospital Infantil de Mexico Federico Gomez
Centro de Investigación y Estudios Avanzados del Instituto Politécnico Nacional
Conditions:
Febrile Neutropenia
Eligibility:
All Genders
9-18 years
Phase:
PHASE2
Brief Summary
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 onco...
Detailed Description
Febrile neutropenia (FN) is a worrying outcome in children receiving chemotherapy because it increments the risk of major complications, reduces quality of life and increments treatment costs. Moreove...
Eligibility Criteria
Inclusion
- 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
- \- Patients whose parents retire the Informed Consent
Key Trial Info
Start Date :
October 19 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2019
Estimated Enrollment :
214 Patients enrolled
Trial Details
Trial ID
NCT03449693
Start Date
October 19 2017
End Date
December 1 2019
Last Update
March 5 2018
Active Locations (1)
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1
Hospital Infantil de Mexico Dr. Federico Gomez
Cuauhtémoc, Mexico City, Mexico, 06720