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Trial record 4 of 192 for:    Oral Cancer | ( Map: Mexico )

Efficacy of Oral Supplementation With Magnesium to Reduce Febrile Neutropenia

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ClinicalTrials.gov Identifier: NCT03449693
Recruitment Status : Recruiting
First Posted : February 28, 2018
Last Update Posted : March 5, 2018
Sponsor:
Collaborators:
Hospital Infantil de Mexico Federico Gomez
Centro de Investigación y Estudios Avanzados del Instituto Politécnico Nacional
Information provided by (Responsible Party):
Osvaldo Daniel Castelan Martinez, Universidad Nacional Autonoma de Mexico

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.

Condition or disease Intervention/treatment Phase
Febrile Neutropenia Dietary Supplement: Magnesium Oxide Supplement Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 214 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Efficacy of Oral Supplementation With Magnesium to Reduce Febrile Neutropenia in Pediatric Oncology Patients Treated With Cisplatin-Based Chemotherapy: Randomized Clinical Trial
Actual Study Start Date : October 19, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever

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 Name: M250

No Intervention: No Supplement
No Intervention



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. Hypomagnesemia [ Time Frame: After randomization until day 30 ]
    Serum magnesium <1.6 mg/mL



Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03449693


Contacts
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Contact: Victoria E Barrios, QFB +52 1 2291290208 victoria.barrios@cinvestav.mx

Locations
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Mexico
Hospital Infantil de Mexico Dr. Federico Gomez Recruiting
Cuauhtémoc, Ciudad De México, Mexico, 06720
Contact: Victoria E Barrios, QFB    +52 1 2291290208    victoria.barrios@cinvestav.mx   
Contact: Miguel A Palomo, MD         
Sponsors and Collaborators
Universidad Nacional Autonoma de Mexico
Hospital Infantil de Mexico Federico Gomez
Centro de Investigación y Estudios Avanzados del Instituto Politécnico Nacional
Investigators
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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 México Dr. Federico Gómez
  Study Documents (Full-Text)

Documents provided by Osvaldo Daniel Castelan Martinez, Universidad Nacional Autonoma de Mexico:

Publications:

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Responsible Party: Osvaldo Daniel Castelan Martinez, Full Time Associate Professor C, Universidad Nacional Autonoma de Mexico
ClinicalTrials.gov Identifier: NCT03449693     History of Changes
Other Study ID Numbers: HIM-2017-085
First Posted: February 28, 2018    Key Record Dates
Last Update Posted: March 5, 2018
Last Verified: March 2018

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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

Additional relevant MeSH terms:
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Neutropenia
Fever
Febrile Neutropenia
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Body Temperature Changes
Signs and Symptoms
Magnesium Oxide
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents