JPRN-jRCTs031180251已完成2 期
Magnesium supplementation therapy to prevent cisplatin-induced acute nephrotoxicity in pediatric cancer: Protocol for a randomised phase 2 trial. - Mg-rPII
Matsui Motohiro0 个研究点目标入组 100 人开始时间: 2019年3月13日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- ot applicable 至 < 20age old（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
研究者
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