Preloading Magnesium Attenuate Cisplatin-induced Nephrotoxicity
- Registration Number
- NCT02481518
- Lead Sponsor
- Mahidol University
- Brief Summary
The purpose of this study is to determine whether magnesium preloading reduce incident of cisplatin induced acute kidney injury in head and neck cancer who receiving low dose cisplatin (40 mg/m2 weekly for 7 weeks).
- Detailed Description
Randomized controlled trial comparing efficacy of magnesium preloading versus normal saline for prevention of acute and chronic nephrotoxicity of cisplatin.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
- Age > 18 years
- Eastern Cooperative Oncology Group score 0-2
- First Diagnosed Head and neck cancer and plan for treatment with cisplatin
- Serum creatinine ≤1.5 mg/dl or eGFR≥60(ml/min/1.73 m2)
Exclusion Criteria
- Prior treatment with cisplatin before randomization
- Uncontrolled concurrent disease
- Pregnancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Magnesium Magnesium Magnesium preloading group : Magnesium preloading for Cisplatin treatment Control Control Control group : Normal saline preloading for cisplatin treatment
- Primary Outcome Measures
Name Time Method Acute kidney injury 7 days after cisplatin administration Comparing serum creatinine before Cisplatin treatment and seven days after cisplatin treatment
- Secondary Outcome Measures
Name Time Method Nephrotoxicity up to 12 weeks Compare serum creatinine before Cisplatin treatment and complete 7 cycles of cisplatin treatment ( up to 12 weeks)
Trial Locations
- Locations (1)
Faculty of medicine, Ramathibodi Hospital, Mahidol University
🇹🇭Bangkok, Thailand