esophageal squamous cell carcinoma esophageal squamous cell carcinoma
Conditions
Interventions
Magnesium sulfate (8 mEq) will be administered before the administration of cisplatin as a IV infuison.
D008278
magnesium sulfate, cisplatin-induced nephrotoxicity
Sponsors
Watanabe Akinori
Mohri Junichi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. A newly-diagnosed, histologically-confirmed esophageal squamous cell carcinoma 2. A esophageal cancer with clinical stage I to IV (UICC 8th edition) 3. Neoadjuvant or induction chemotherapy regimen including high-dose cisplatin (> 70 mg/m2) 4. Age of 20 to 80 years old 5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2 6. Adequate organ function: - Absolute neutrophil count > 2,000/mm3 - Platelet count > 100,000/mm3 - Hemoglobin > 10.0 g/dL - Total bilirubin 50 mL/min 7. Serum magnesium level < 3.0 mg/dL 8. Written informed consent
Exclusion criteria
Exclusion criteria: 1. A history of chemotherapy for cancer in another organ 2. Use of a reduced dose of cisplatin from the time of initial treatment 3. A history of hypersensitivity to magnesium products 4. Having myasthenia gravis 5. A history of therapy for heart block 6. Pregnant or breast feeding women, women of child-bearing potential 7. Patients who are judged inappropriate for entry into this study by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Grade > 2 serum creatinine elevation according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Incidence and severity of nephrotoxicity based on creatinine clearance (Ccr) and estimated glomerular filtration rate (eGFR) 2. Changes in serum creatinine levels, Ccr and eGFR during chemotherapy 3. Changes in urinary biomakers (N-acetyl-B-D-glucosaminidase (NAG), B2-microglobulin, and Liver-type fatty acid-binding protein (L-FABP)) during chemotherapy 4. Change in serum magnesium level during chemotherapy 5. Rates of chemotherapy dose delays, reductions, or discontinuations 6. Rates of changing chemotherapy regimen 7. Relative dose intensity 8. Evaluation of clinical and pathological responses according to the Response Evaluation Criteria in Solid Tumors (RECIST) and pathological criteria 9. Adverse event incidence based on CTCAE version 5.0 10. Incidence and severity of nephrotoxicity based on serum creatinine levels, Ccr, and eGFR for high-risk patients who have several risk factors for cisplatin-induced nephrotoxicity | — |
Contacts
Public ContactJunichi Mohri
Kitasato University
Outcome results
None listed