Efficacy of Oral Supplementation With Magnesium to Reduce Febrile Neutropenia

March 1, 2018 updated by: Osvaldo Daniel Castelan Martinez, Universidad Nacional Autonoma de Mexico

Efficacy of Oral Supplementation With Magnesium to Reduce Febrile Neutropenia in Pediatric Oncology Patients Treated With Cisplatin-Based Chemotherapy: Randomized Clinical Trial

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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. Moreover, it is the most common diagnosis in pediatric oncology patients that enter emergency rooms and the second most important cause of hospitalization, just behind hospitalization for administration of chemotherapy.

In Mexico, incidence of FN is of 62% of children with solid tumors treated with cisplatin-based chemotherapy (CBC). Cisplatin is one of the most nephrotoxic drugs being used in clinical settlements. The assessment of nephrotoxicity is made with the manifestation of tubular damage that causes electrolyte losses, specially of magnesium. Recently, our investigation group reported that there is an association of hypomagnesemia and the apparition of FN. This association has a biologic explanation in the fact that magnesium is a necessary cofactor for the neutrophil's diapedesis and the activation of complement cascade. To our knowledge, the role of magnesium supplementation has not been explored. With this evidence in mind, the investigators wondered if oral supplementation with magnesium will reduce FN episodes in pediatric oncology patients treated with CBC.

Objective: Determine the efficacy of oral supplementation with magnesium to reduce FN episodes in pediatric oncology patients treated with CBC.

Hypothesis: Previous clinical trials made in adult population have reported that supplementation with magnesium salts reduce episodes of hypomagnesemia in between 13 and 50%. Thus, oral supplementation with magnesium oxide will reduce 20% of FN episodes in pediatric oncology patients treated with CBC.

Materials and Methods: Randomized Clinical Trial, open-label, parallel groups of children over the age of nine with solid tumors treated with CBC at the Haemato-Oncology Department of the Hospital Infantil de México. To prove the hypothesis, it is required to randomize 107 CBC cycles to the intervention group and 107 CBC cycles to the control group. The sample size calculation was made by using the two proportions formula. Randomize of children will be made when they receive CBC indication. Patients assigned to the intervention group will receive institutional attention protocol plus a bottle of magnesium oxide, at the moment of hospitalization discharge. Patients assigned to the control group will receive only institutional attention protocol. The follow-up of patients will be made until an episode of FN appears or until the patient comes back for another CBC cycle. FN assessment will be measured with a unique temperature >38.3°C or a sustained temperature >38°C over the course of an hour plus a count of neutrophils under 1000 cells/mm3. The efficacy of oral supplementation with magnesium oxide will be determined by a Relative Risks calculation with confidence interval of 95% (CI95%). Moreover, Absolute Risk Reduction will be calculated, as well as Necessary Number to Treat. To adjust the principal variable a multivariate analysis will be made with a multiple logistic regression. The analysis will be made by protocol and by intention to treat.

Study Type

Interventional

Enrollment (Anticipated)

214

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Ciudad De México
      • Cuauhtémoc, Ciudad De México, Mexico, 06720
        • Recruiting
        • Hospital Infantil de Mexico Dr. Federico Gomez
        • Contact:
        • Contact:
          • Miguel A Palomo, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Magnesium Oxide Supplement
Magnesium Oxide 250 mg tablet, daily for 30 days.
Dietary supplement: Magnesium Oxide Supplement
Magnesium Oxide tablet
Other Names:
  • M250
No Intervention: No Supplement
No Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Febrile Neutropenia
Time Frame: After randomization until day 30
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time passed from cisplatin-based chemotherapy until the apparition of febrile neutropenia
Time Frame: After randomization until day 30
Total of days passed from the randomization up to the apparition of febrile neutropenia
After randomization until day 30
Safety of Oral Supplementation with Magnesium
Time Frame: Evaluate the apparition of adverse effects of oral supplement of magnesium oxide Time Frame: After randomization until day 30
Evaluate the apparition of adverse effects of oral supplement of magnesium oxide
Evaluate the apparition of adverse effects of oral supplement of magnesium oxide Time Frame: After randomization until day 30
Hypomagnesemia
Time Frame: After randomization until day 30
Serum magnesium <1.6 mg/mL
After randomization until day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Nacional Autonoma de Mexico

Collaborators

Hospital Infantil de Mexico Federico Gomez
Centro de Investigación y Estudios Avanzados del Instituto Politécnico Nacional

Investigators

  • Principal Investigator: Osvaldo D Castelán, PhD, Universidad Nacional Autónoma de México. Facultad de Estudios Superiores Zaragoza
  • Principal Investigator: Miguel A Palomo, PhD, Hospital Infantil de Mexico Dr. Federico Gomez

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 19, 2017

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

February 21, 2018

First Submitted That Met QC Criteria

February 21, 2018

First Posted (Actual)

February 28, 2018

Study Record Updates

Last Update Posted (Actual)

March 5, 2018

Last Update Submitted That Met QC Criteria

March 1, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HIM-2017-085

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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