Comparative Study of Different Doses of Magnesium as a Protective Agent in Cisplatin Induced Nephrotoxicity in Patients With Head and Neck Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 75 patients received magnesium with Treatment related Adverse Events as Assessed by CTCAE v5.0 At the end of cycle 7 of chemotherapy (each cycle is 7days)
研究概览
简要总结
The goal of this [ type of study: intervential study is to compare between different doses of magnesium to prevent cisplatin induced nephrotoxicity.] In 75 participant population with head and neck cancer recieved cisplatin it aims to answer are: • • optimal doses of magnesium as 3 groups each group take 1gm of magnesium then second group take 2gm of magnesium and finally third group take 3gm of magnesium Researchers will compare [ 3 groups ] to see if [ magnesium has effects in prevention cisplatin nephrotoxicity].
详细描述
This study aims to:
- Investigate the potential role of magnesium in prevention of cisplatin induced nephrotoxicity in patient with head and neck cancer.
- Determine the optimal dose of magnesium (Mg).
Study Design :
- This is a randomized, controlled, parallel, prospective clinical study included 75 patients with head and neck cancer presented and treated at Clinical Oncology Department Tanta University Hospital, Tanta.
- This study will be approved by Research Ethics Committee of Tanta University.
- Randamization will be carried out based on days of hospital admission.
Treatment Protocol :
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •diagnosed with head and neck cancer recieved cisplatin ECOG <2 eGFR>59 ml/min/1.73 Adequate hematological parameters
排除标准
- •pregnant and lactating women Using of nephrotoxic drugs as NSAIDs Patients with hypersensitivity to any drug used Diabetic patients Patients with cardiovascular diseases
研究组 & 干预措施
Group 1
(n=25): receive cisplatin with hydration 1000mg magnesium (8 q) intravenous infusion ( IVI ).
干预措施: cisplatin with hydration magnesium (Drug)
Group 2
(n=25): receive cisplatin with hydration 2000mg magnesium (16 Meq) ( IVI ).
干预措施: cisplatin with hydration magnesium (Drug)
Group 3
(n=25): receive cisplatin with hydration 3000 mg magnesium (32 Meq) ( IVI ).
干预措施: cisplatin with hydration magnesium (Drug)
结局指标
主要结局
75 patients received magnesium with Treatment related Adverse Events as Assessed by CTCAE v5.0 At the end of cycle 7 of chemotherapy (each cycle is 7days)
时间窗: At the end of cycle 7 of chemotherapy (each cycle is 7days)
Optimal doses of magnesium
次要结局
- 75 patients received magnesium and access change of biomarkers levels From Baseline in nephrotoxicity at the end of cycle 7 of chemotherapy (each cycle is 7days)(At the end of cycle 7 of chemotherapy (each cycle is 7days))
研究者
mohamed saad saad younis
clinical pharmacist
Tanta University