- Design
- Randomised controlled trial, four arms
- Population
- 100 patients with head and neck squamous cell carcinoma on weekly cisplatin and radiotherapy
- Primary outcome
- Urinary and serum markers of cisplatin nephrotoxicity
- Effect
- Lower urinary KIM-1 and NGAL with magnesium vs control (P<0.05)
This randomised trial allocated 100 patients with head and neck squamous cell carcinoma, receiving weekly cisplatin 40 mg/m² with radiotherapy for seven cycles, to no magnesium or to 1 g, 2 g or 3 g of intravenous magnesium sulphate with each cycle.
All magnesium groups had lower urinary kidney injury molecule-1 and NGAL than controls. Serum markers of apoptosis and oxidative stress were lower in the 3 g group. The authors also reported better quality of life with magnesium. The abstract does not report creatinine, eGFR or rates of clinical acute kidney injury.
Magnesium supplementation with cisplatin is already common practice in many centres, because cisplatin causes magnesium wasting. This small trial supports it on biomarkers, but it does not show fewer cases of clinical kidney injury, and four groups of 25 is too small to compare doses reliably.
- Continue magnesium supplementation with cisplatin per local protocol.
- Check serum magnesium before each cisplatin cycle.
- Do not rely on biomarker improvements as proof of fewer clinical kidney injuries.
- Monitor creatinine and urine output alongside any supplementation.
Why it matters
Weekly cisplatin with radiotherapy is the commonest head and neck regimen in India, and kidney injury limits it.
Don't overread it
Surrogate biomarkers in a small trial; it does not show fewer clinical kidney injuries.
The statistics, in plain English
The trial reported p-values for differences in biomarkers rather than effect sizes for clinical outcomes. Biomarkers such as KIM-1 and NGAL signal tubular injury earlier than creatinine but are surrogates. Twenty-five patients per group limits precision.
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