Magnesium supplementation therapy to prevent cisplatin-induced acute nephrotoxicity in pediatric cancer: a randomized phase-2 trial.
Study Goal
The researchers aimed to determine whether magnesium supplementation could prevent cisplatin-induced nephrotoxicity in pediatric cancer patients undergoing chemotherapy.
Results Summary
The study found no significant difference in serum creatinine levels or other biomarkers between groups with or without magnesium supplementation, though magnesium levels were higher in the supplemented group. No adverse events related to magnesium administration were observed.
Population
Pediatric cancer patients under 20 years old receiving cisplatin-containing chemotherapy.
Effective Dosage
Not specified
Duration
Duration of chemotherapy courses (specific length not detailed)
Interactions
None mentioned
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
magnesium (Mg) supplementation | no change | preventing cisplatin-induced nephrotoxicity (CIN) | pediatric cancer patients | no significant difference | failed to detect a statistically significant benefit | #1 |
magnesium (Mg) supplementation | no change | proportion of chemotherapy courses resulting in elevated serum creatinine | pediatric cancer patients | group A: 10% vs. group B: 6%; P = 0.465 | no significant difference | #2 |
magnesium (Mg) supplementation | no change | other biomarkers | pediatric cancer patients | - | no significant difference observed | #3 |
magnesium (Mg) supplementation | increase | Mg value during chemotherapy | pediatric cancer patients | - | significantly higher | #4 |
magnesium (Mg) supplementation | no change | safety | pediatric cancer patients | - | No adverse events related | #5 |
BACKGROUND: The present study aimed to examine the effect of magnesium (Mg) supplementation on cisplatin-induced nephrotoxicity (CIN) in pediatric cancer patients. METHODS: The present phase-2, open-label, multicenter, randomized controlled trial enrolled patients aged less than 20 years who were scheduled to receive cisplatin-containing chemotherapy and randomly allocated them at a ratio of 1:1 to a Mg supplementation arm with even-numbered chemotherapy courses (arm AB) or another arm with odd-numbered courses (arm BA). Analysis objects were reconstructed into two groups depending on whether the chemotherapy course had Mg supplementation (group B) or not (group A). The primary outcome was the proportion of chemotherapy courses resulting in elevated serum creatinine per chemotherapy course. The secondary outcomes included efficacies evaluated using other biomarkers and the safety of the Mg supplementation. RESULTS: Twenty-eight patients were randomly allocated to either group (16 to arm AB and 12 to arm BA). The baseline characteristics of the groups were similar. There was no significant difference in the proportion of courses with increased serum creatinine between the groups (group A: 10% vs. group B: 6%; P = 0.465) nor was any significant difference observed in other biomarkers during any chemotherapy course. The Mg value during chemotherapy was significantly higher in group B than that in group A. No adverse events related to magnesium administration were observed. CONCLUSIONS: The study design, which treated a single chemotherapy course as a study object, failed to detect a statistically significant benefit of Mg supplementation for preventing CIN in pediatric cancer patients. TRIAL REGISTRATION: JRCT ( https://jrct.niph.go.jp/ ) Identifier UMIN000029215 jRCTs031180251. UMIN-CTR ( http://www.umin.ac.jp/icdr/index.html ) Identifier UMIN000029215.