[Assessment of the protective effect of calcium-magnesium infusion and glutathione on oxaliplatin-induced neurotoxicity].
Level 2 - randomized trial
Individual randomized controlled trial
What was done
A randomized, double-blind, placebo-controlled trial evaluated 93 patients with solid tumors receiving FOLFOX4 chemotherapy. Patients were allocated to receive calcium-magnesium infusion (Ca/Mg, n = 29), glutathione (GSH, n = 33), or normal saline placebo (chemotherapy alone, n = 31) simultaneously with chemotherapy. The incidence and severity of acute and chronic oxaliplatin-induced neurotoxicity were assessed at cycles 3, 6, and 9, alongside changes in ECOG performance status.
What was found
Acute neurotoxicity occurred in 82.8% of the Ca/Mg group, 90.9% of the GSH group, and 93.5% of the control group. At cycle 3, grade 1–2 chronic neurotoxicity rates were 37.9%, 48.5%, and 42.0%, respectively, with no grade 3 cases. After 6 cycles, grade 1–2 neuropathy was 68.2% (Ca/Mg), 88.9% (GSH), and 85.2% (control), with grade 3 neuropathy reported in 5 patients overall. After 9 cycles, grade 1–2 neuropathy was 81.3% (Ca/Mg), 90.0% (GSH), and 92.9% (control), with grade 3 neuropathy in 2 additional patients. Differences among the three groups were not statistically significant, and ECOG score changes were similar.
Why it matters
These findings suggest that neither calcium-magnesium nor glutathione infusions provide protective efficacy against oxaliplatin-induced peripheral neuropathy.
Limits
The sample size is relatively small (93 patients across three arms), limiting power to detect modest effect sizes. The abstract does not provide exact p-values, confidence intervals, specific tumor types, patient dropout rates across cycles, or long-term oncologic outcomes.
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