Academic journal article Iranian Journal of Public Health

Effect of Oral Magnesium Oxide Supplementation on Cisplatin-Induced Hypomagnesemia in Cancer Patients: A Randomized Controlled Trial

Academic journal article Iranian Journal of Public Health

Effect of Oral Magnesium Oxide Supplementation on Cisplatin-Induced Hypomagnesemia in Cancer Patients: A Randomized Controlled Trial

Article excerpt

Introduction

Hypomagnesaemia is one of the well-known and common side effects of cisplatin that was first reported in cancer patients about three decades ago (1, 2). Magnesium (Mg) is the second most abundant intracellular cation in the human body. It is an essential co-factor for many enzymes involved in cellular metabolic pathways (3).

Although Mg homeostasis is regulated by intestinal absorption and renal excretion (4, 5), the kidney has the main role in the regulation of serum Mg concentration. Cisplatin as a part of some chemotherapy regimens causes renal tubular necrosis resulting in decreased tubular reabsorption of Mg (4-12).

Prevalence of cisplatin-induced hypomagnesaemia in these patients is between 29 to 100% (1, 7, 1321). Incidence and severity of hypomagnesaemia depend on cumulative doses of cisplatin, chemotherapy cycles and periods of cisplatin administration (13, 16-18, 22-24). Mg deficiency can cause neurological-muscle disorders, electrocardiographic changes, mental disorders, electrolyte disturbances and even sudden death because of tetany or heart attack (14, 15, 19, 25-28).

The first Mg supplementation study in cancer patients receiving cisplatin-based regimen was done in 1982 (28). After that several interventional investigations in this area reported various results; positive effects (29-34), or no effects of oral or intravenous Mg supplementation (14, 17, 35). Although most studies have shown that supplementation with different doses of Mg salts could reduce or prevent hypomagnesaemia, but still there is no certain guideline; a guideline that clearly determines the best amount, type and duration of Mg salts supplementation according to cisplatin doses to attain optimum effect.

In Iran, we have only accessed to magnesium oxide (MgO) tablet for oral Mg supplementation to prevent or treatment of hypomagnesaemia therefore this study was designed to find out its effect on cisplatin-induced hypomagnesaemia in our patients. In this investigation, the effect of MgO according to cisplatin dose was evaluated on the cisplatin-induced hypomagnesaemia and serum Mg changes in cancer patients.

Materials and Methods

Subjects

This study was performed between December 2009 and May 2011 in Oncology Ward of Rasoul-eAkram Hospital of Iran University of Medical Sciences (IUMS), Tehran, Iran. Adult patients (≥16 y/o) could be participated in the study if they had newly diagnosed non-leukemia neoplasm and were scheduled for starting cisplatin-based chemotherapy regimens in six cycles, were not suffering from hypomagnesaemia, renal failure and alcoholism and were not using diuretics, aminoglycosides, cyclosporine, amphotericin B and Mgcontaining medicines and supplements. Exclusion criteria were death before the end of intervention or discontinuing intake of MgO supplement.

To detect the mean difference of MgO supplement with a standardized difference of moderate (SD=0.5) between two groups, considering type one error of 0.05 and power of 80%, we calculated 30 subjects per group. Considering loss of patients in follow-up period about 10%, 34 patients were determined for each group. Finally, 69 patients allocated to the intervention and the control groups with minimization method, because they needed to match according to cisplatin dose and number of cycles.

Study design

In this open-label parallel study, patients in the intervention group received oral MgO supplement (250 mg tablet-21Century Health Care, Inc., USA, equal to 150 mg Mg) according to Cisplatin dose: 500 mg MgO for each 50 mg/m2 of cisplatin, as 23 3 daily doses after completion of each chemotherapy cycle continuing to the next cycle and also 2 or 3 wk after the final cycle. The control group did not receive any supplementation as placebo during treatment. The supplementation method was a combination design of Bodnar, Martin and Hodgkinson studies (13, 29, 36).

The study protocol was approved by the Ethics Committee of IUMS and the written informed consents were obtained from all participants of the study. …

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