Newly diagnosed malignant disease
Conditions
Interventions
In this study, participants will be randomised in equal populations into two arms. One arm will receive cisplatin-containing chemotherapy without Mg in the first course, then start Mg supplementation
Sponsors
Matsui Motohiro
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Contacts
Public ContactMotohiro Matsui
Pediatric Hematology Oncolocy, Tokyo Metropolitan Children's Medical Center
Outcome results
None listed