Oral magnesium supplements for cancer treatment-induced hypomagnesemia: Results from a pilot randomized trial
Awan A, Basulaiman B, Stober C, Clemons M, Fergusson D, Hilton J, Al Ghareeb W, Goodwin R, Ibrahim M, Hutton B, Vandermeer L, Mallick R, Vickers MM
Health science reports · 6 citations
Review labels
Neutral facts our review recorded about how this study was done. They describe method, never whether we like the result.
How it was studied
- Design
- Randomized controlled trial (classified by our AI screen)
- Studied in
- People
- Main outcome
- Health markers and function
Who paid for it
- Funding
- Independent funding
- Authors
- At least one author declares a financial tie to industry
Based on full-text disclosure statement.
Publication
- Published
- 2021-12-01 · Health Sci Rep · vol. 4 · issue 4 · p. e443
- Publisher
- Wiley
- Cited
- 8 citations · more than 63% of similar papers · 0.6× the field average
- References
- 25 works
- Access
- Open access (journal) · CC-BY
- Research areas
- Magnesium in Health and Disease · Parathyroid Disorders and Treatments · Potassium and Related Disorders
- Keywords
- Medicine, Randomized controlled trial, Hypomagnesemia, Tolerability, Internal medicine, Magnesium, Adverse effect
13 authors
From CA
- Arif Ali AwanOttawa Hospital
- Bassam Mohammed BasulaimanOttawa Hospital
- Carol StoberOntario Institute for Cancer Research; Ottawa Hospital; Ottawa Hospital Research Institute
- Mark J. ClemonsOntario Institute for Cancer Research; University of Ottawa; Ottawa Hospital; Ottawa Hospital Research Institute
- Dean A. FergussonUniversity of Ottawa; Ottawa Hospital; Ottawa Hospital Research Institute
- John Frederick HiltonOntario Institute for Cancer Research; Ottawa Hospital; Ottawa Hospital Research Institute
Abstract
Background and aims
Optimal management of cancer treatment-induced hypomagnesemia (hMg) is not known. We assessed the feasibility of using a novel pragmatic clinical trials model to compare two commonly used oral Mg replacement strategies.
Methods
Patients with grade 1 to 3 hMg while receiving either platinum-based chemotherapy or epidermal growth factor receptor inhibitors (EGFRI) were randomized to oral magnesium oxide (MgOx) or oral magnesium citrate (MgCit). The trial methodology utilized the integrated consent model. Feasibility would be successful if; accrual rate was ≥5 patients a month and if measures of patient and physician engagement, were > 50%. Secondary endpoints included; comparison of Mg levels, cardiac arrhythmias, and rates of treatment delay/hospitalizations.
Results
From July 2016 to December 2017, an average of 1 patient a month was accrued. All 15 eligible and approached patients consented to participate in the study (100% engagement) and 7/15 were randomized to MgOx and 8/15 to MgCit. The percentage of physicians who approached patients for the study was 4 of 6 (66.6% engagement). The mean slope of change in Mg (mmol/L/day) was 0.0022 (95% CI: -0.0001 to 0.0044) for MgOx and 0.0006 (95% CI, -0.0012 to 0.0024) for MgCit (P = .2123). Three patients (20%) required IV magnesium while on the study (2 MgCit and 1 MgOx). Grade 1 diarrhea occurred in 3 patients in the MgCit arm.
Conclusion
Despite oral magnesium tolerability and meeting most of its feasibility endpoints, this study did not meet its target accrual rate. Alternative designs would be necessary for a definitive efficacy study.
Abstract via Europe PMC. Copyright remains with the authors or publisher (CC BY).
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