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: 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.
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Authors | Arif Awan, Bassam Basulaiman, Carol Stober, Mark Clemons, Dean Fergusson, John Hilton, Waleed Al Ghareeb, Rachel Goodwin, Mohammed Ibrahim, Brian Hutton, Lisa Vandermeer, Ranjeeta Mallick, Michael M Vickers |
Journal | Health science reports
(Health Sci Rep)
Vol. 4
Issue 4
Pg. e443
(Dec 2021)
ISSN: 2398-8835 [Electronic] United States |
PMID | 34938893
(Publication Type: Journal Article)
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Copyright | © 2021 The Authors. Health Science Reports published by Wiley Periodicals LLC. |