NCT03449693

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 oncology patients treated with cisplatin-based chemotherapy.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
214

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 19, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 21, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 28, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

March 5, 2018

Status Verified

March 1, 2018

Enrollment Period

2.1 years

First QC Date

February 21, 2018

Last Update Submit

March 1, 2018

Conditions

Febrile Neutropenia

Outcome Measures

Primary Outcomes (1)

  • Febrile Neutropenia

    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.

    After randomization until day 30

Secondary Outcomes (3)

  • Time passed from cisplatin-based chemotherapy until the apparition of febrile neutropenia

    After randomization until day 30

  • Safety of Oral Supplementation with Magnesium

    Evaluate the apparition of adverse effects of oral supplement of magnesium oxide Time Frame: After randomization until day 30

  • Hypomagnesemia

    After randomization until day 30

Study Arms (2)

Magnesium Oxide Supplement

EXPERIMENTAL

Magnesium Oxide 250 mg tablet, daily for 30 days.

Dietary Supplement: Magnesium Oxide Supplement

No Supplement

NO INTERVENTION

No Intervention

Interventions

Magnesium Oxide SupplementDIETARY_SUPPLEMENT

Magnesium Oxide tablet

Also known as: M250
Magnesium Oxide Supplement

Eligibility Criteria

Age9 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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
  • Patients whose parents do not sign the Informed Consent
  • Patients with magnesium losing tubulopathy
  • Patients with hypomagnesemia previous to the cisplatin-based chemotherapy

You may not qualify if:

  • \- Patients whose parents retire the Informed Consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Infantil de Mexico Dr. Federico Gomez

Cuauhtémoc, Mexico City, 06720, Mexico

RECRUITING

Related Publications (11)

  • Freifeld 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: 8723296BACKGROUND

  • Castagnola 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: 9833301BACKGROUND

  • Mueller 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: 25345994BACKGROUND

  • Klaassen 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: 10694551BACKGROUND

  • Castelan-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: 26907640BACKGROUND

  • Lajer H, Daugaard G. Cisplatin and hypomagnesemia. Cancer Treat Rev. 1999 Feb;25(1):47-58. doi: 10.1053/ctrv.1999.0097.

    PMID: 10212589BACKGROUND

  • Knijnenburg 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.

    PMID: 24101439BACKGROUND

  • Willox JC, McAllister EJ, Sangster G, Kaye SB. Effects of magnesium supplementation in testicular cancer patients receiving cis-platin: a randomised trial. Br J Cancer. 1986 Jul;54(1):19-23. doi: 10.1038/bjc.1986.147.

    PMID: 3524645BACKGROUND

  • Martin M, Diaz-Rubio E, Casado A, Lopez Vega JM, Sastre J, Almenarez J. Intravenous and oral magnesium supplementations in the prophylaxis of cisplatin-induced hypomagnesemia. Results of a controlled trial. Am J Clin Oncol. 1992 Aug;15(4):348-51. doi: 10.1097/00000421-199208000-00016.

    PMID: 1514533BACKGROUND

  • Zarif Yeganeh M, Vakili M, Shahriari-Ahmadi A, Nojomi M. Effect of Oral Magnesium Oxide Supplementation on Cisplatin-Induced Hypomagnesemia in Cancer Patients: A Randomized Controlled Trial. Iran J Public Health. 2016 Jan;45(1):54-62.

    PMID: 27057522BACKGROUND

  • Castelan-Martinez OD, Palomo-Colli MA, Barrios-Lopez VE, Silva-Jivaja KM, Juarez-Villegas LE, Castaneda-Hernandez G, Sanchez-Rodriguez MA. 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. Cancer Chemother Pharmacol. 2020 Nov;86(5):673-679. doi: 10.1007/s00280-020-04155-4. Epub 2020 Oct 8.

    PMID: 33030582DERIVED

MeSH Terms

Conditions

Febrile Neutropenia

Condition Hierarchy (Ancestors)

NeutropeniaAgranulocytosisLeukopeniaCytopeniaHematologic DiseasesHemic and Lymphatic DiseasesLeukocyte Disorders

Study Officials

  • Osvaldo D Castelán, PhD

    Universidad Nacional Autónoma de México. Facultad de Estudios Superiores Zaragoza

    PRINCIPAL INVESTIGATOR

  • Miguel A Palomo, PhD

    Hospital Infantil de México Dr. Federico Gómez

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Victoria E Barrios, QFB

CONTACT

+52 1 2291290208victoria.barrios@cinvestav.mx

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Two groups: Intervention group and control group. The intervention group will receive institutional care protocol plus oral supplementation with magnesium. The control group will receive institutional care protocol only.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Time Associate Professor C

Study Record Dates

First Submitted

February 21, 2018

First Posted

February 28, 2018

Study Start

October 19, 2017

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

March 5, 2018

Record last verified: 2018-03

Locations

ME(1)