Magnesium supplementation therapy to prevent cisplatin-induced acute nephrotoxicity in pediatric cancer: Protocol for a randomised phase 2 trial.

Phase 2

• Conditions: ewly diagnosed malignant disease

• Registration Number: JPRN-jRCTs031180251
• Lead Sponsor: Matsui Motohiro

Brief Summary

In pediatric cancer patients, we did not find significant advantage of magnesium supplementation during chemotherapy in the frequency of cisplatin related acute nephrotoxicity measured by creatinine or other renal injury parameters at least with our methodology using each chemotherapy course as a subject.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-13
• Study Completion: 2022-06-28
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Newly diagnosed malignant disease.
2. Age less than 20 years.
3. Plan to undergo chemotherapy containing cisplatin equal or more than 60 mg/m2/course. Cisplatin must be administered in 1-day schedule, or 5-day schedule. Cycle of the chemotherapy courses must be equal to, or longer than 21 days for appropriate observation.
4. Eastern Clinical Oncology Group Performance Status 0, 1, or 2.
5. Written informed consent from participant (older than 16 years only) and guardian.

Exclusion Criteria

1. History of allergic reaction to magnesium.
2. Cardiac dysfunction necessitate medication.
3. Uncontrollable active infection.
4. Current use of hemodialysis.
5. Pregnancy or lactation.
6. Other problems which investigators judge inappropriate for study entry.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary endpoint is proportion of chemotherapy courses which result in elevated serum creatinine equal to, or more than 50% of the pre-value. Four secondary endpoints are (1) proportion of chemotherapy courses result in renal dysfunction by means of cystatin-C in serum, B2M, L-FABP, NGAL, and NAG in urine

Secondary Outcome Measures

Name	Time	Method
Four secondary endpoints are (1) proportion of chemotherapy courses result in renal dysfunction by means of cystatin-C in serum, B2M, L-FABP, NGAL, and NAG in urine, (2) comparison between two groups of kinetics of cystatin-C in serum, B2M, L-FABP, NGAL, and NAG in urine during chemotherapy course, (3) comparison between two groups of kinetics of serum Mg value as a surrogate of pharmacokinetics of Mg sulfate, and (4) Safety analyses of Mg supplementation.