Febrile NeutropeniaPhase 2NCT03449693
Efficacy of Oral Supplementation With Magnesium to Reduce Febrile Neutropenia
A Phase 2 study testing Magnesium Oxide Supplement in people with Febrile Neutropenia, run by Universidad Nacional Autonoma de Mexico at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 18 years
- Conditions the study is for
- Febrile Neutropenia
- What is being tested?
- Magnesium Oxide Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- 1 siteMexico
- Study dates
- 19 Oct 2017to Dec 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Patients whose parents retire the Informed Consent
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Hospital Infantil de Mexico Dr. Federico Gomez
Cuauhtémoc, Mexico City, 06720
Victoria E Barrios, QFB, +52 1 2291290208, victoria.barrios@cinvestav.mx
Miguel A Palomo, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Febrile Neutropenia
- Being tested
- Magnesium Oxide Supplement
- Medical subject headings
- Febrile Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium Oxide SupplementDietary supplement
Also called M250
Magnesium Oxide tablet
| Study group | Role | What they receive |
|---|---|---|
| Magnesium Oxide Supplement | Experimental | Magnesium Oxide 250 mg tablet, daily for 30 days. Receives: Dietary Supplement: Magnesium Oxide Supplement |
| No Supplement | No intervention | No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: After randomization until day 30
Secondary outcomes (3)
Time passed from cisplatin-based chemotherapy until the apparition of febrile neutropenia
Total of days passed from the randomization up to the apparition of febrile neutropenia
Measured: After randomization until day 30
Safety of Oral Supplementation with Magnesium
Evaluate the apparition of adverse effects of oral supplement of magnesium oxide
Measured: Evaluate the apparition of adverse effects of oral supplement of magnesium oxide Time Frame: After randomization until day 30
Hypomagnesemia
Serum magnesium <1.6 mg/mL
Measured: After randomization until day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2018
- Study start19 Oct 2017
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Febrile NeutropeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 214 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Nacional Autonoma de Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Infantil de Mexico Federico Gomez, Centro de Investigación y Estudios Avanzados del Instituto Politécnico Nacional
- Responsible party
- Principal investigator, Osvaldo Daniel Castelan Martinez, Universidad Nacional Autonoma de Mexico
- Investigators
- Osvaldo D Castelán, PhD, Principal investigator, Universidad Nacional Autónoma de México. Facultad de Estudios Superiores ZaragozaMiguel A Palomo, PhD, Principal investigator, Hospital Infantil de México Dr. Federico Gómez
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03449693
- Sponsor's protocol ID
- HIM-2017-085
- Status last verified
- Mar 2018
- First submitted
- 21 Feb 2018
- Last updated
- 5 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 8723296Castagnola 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.
PubMed 9833301Mueller 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.
PubMed 25345994Klaassen 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.
PubMed 10694551Castelan-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.
PubMed 26907640Lajer H, Daugaard G. Cisplatin and hypomagnesemia. Cancer Treat Rev. 1999 Feb;25(1):47-58. doi: 10.1053/ctrv.1999.0097.
PubMed 10212589Knijnenburg 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.
PubMed 24101439Willox 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.
PubMed 3524645Martin 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.
PubMed 1514533Zarif 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.
PubMed 27057522Castelan-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.
PubMed 33030582
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Oral Supplementation With Magnesium to Reduce Febrile Neutropenia in Pediatric Oncology Patients Treated With Cisplatin-Based Chemotherapy: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03449693
- Acronym / sponsor ID
- HIM-2017-085
- Conditions
- Febrile Neutropenia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 214 participants (estimated)
- Lead sponsor
- Universidad Nacional Autonoma de MexicoUniversity, hospital or other
- Collaborators
- Hospital Infantil de Mexico Federico Gomez, Centro de Investigación y Estudios Avanzados del Instituto Politécnico Nacional
- Study start
- 19 Oct 2017 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 28 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Magnesium Oxide Supplement | Experimental | Dietary Supplement: Magnesium Oxide SupplementMagnesium Oxide 250 mg tablet, daily for 30 days. |
| No Supplement | No intervention | –No Intervention |
Who may qualify
- Ages
- 9 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (1 listed)
- Patients whose parents retire the Informed Consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnesium Oxide SupplementAlso: M250Magnesium Oxide tablet | Dietary supplement | Magnesium Oxide Supplement |
Primary outcome
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.
3 secondary outcomes
Time passed from cisplatin-based chemotherapy until the apparition of febrile neutropenia
Time frame: 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
Hypomagnesemia
Time frame: After randomization until day 30
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2018.
- Background: PubMed 8723296Freifeld 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.
- Background: PubMed 9833301Castagnola 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.
- Background: PubMed 25345994Mueller 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.
- Background: PubMed 10694551Klaassen 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.
- Background: PubMed 26907640Castelan-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.
- Background: PubMed 10212589Lajer H, Daugaard G. Cisplatin and hypomagnesemia. Cancer Treat Rev. 1999 Feb;25(1):47-58. doi: 10.1053/ctrv.1999.0097.
- Background: PubMed 24101439Knijnenburg 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.
- Background: PubMed 3524645Willox 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.
- Background: PubMed 1514533Martin 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.
- Background: PubMed 27057522Zarif 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.
- Derived from this study: PubMed 33030582Castelan-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Osvaldo D Castelán, PhD principal investigator
Universidad Nacional Autónoma de México. Facultad de Estudios Superiores Zaragoza
Miguel A Palomo, PhD principal investigator
Hospital Infantil de México Dr. Federico Gómez
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Magnesium Oxide Supplement in people with Febrile Neutropenia, run by Universidad Nacional Autonoma de Mexico at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Victoria E Barrios, QFB (+52 1 2291290208, victoria.barrios@cinvestav.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Febrile Neutropenia (time frame: After randomization until day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03449693, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2018.