Evaluation of Alpha-Lipoic Acid in Mitigating Cisplatin-Induced Nephrotoxicity in Oncology Patients
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in SCr and CrCl in patients receiving Cisplatin Chemotherapy + Alpha-Lipoic Acid compared to Control Group
研究概览
简要总结
To assess the nephroprotective efficacy of Alpha-Lipoic Acid in preventing cisplatin-induced nephrotoxicity in oncology patients by monitoring renal function changes
详细描述
This proof-of-concept study will be a randomized, controlled, open label clinical trial with parallel group assignment, designed to evaluate the nephroprotective effect of alpha lipoic acid (ALA) in patients receiving cisplatin based chemotherapy.
- Allocation: Randomized (1:1).
- Interventional model: Parallel assignment.
- Masking: None (open label).
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years. Histologically confirmed solid malignancy. Planned treatment with cisplatin starting from a dose of 60 mg/m2 per cycle (21-28 days each or fractionated).
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-
- •Baseline serum creatinine within normal range or estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73 m
- •Ability to provide informed consent.
排除标准
- •Pre existing renal impairment (eGFR < 60〖" mL/min/1.73 m" 〗^2or serum creatinine > 1.5 × upper limit of normal).
- •Concomitant use of known nephrotoxic drugs that cannot be stopped (e.g., aminoglycosides, amphotericin B, high dose NSAIDs).
- •Uncontrolled hypertension, decompensated heart failure, or severe hepatic impairment.
- •Known allergy or intolerance to ALA. Pregnancy or lactation. Participation in another interventional clinical trial.
研究组 & 干预措施
Standard Hydration
o Standard preventive measures for cisplatin nephrotoxicity (e.g., pre and post hydration, antiemetics, magnesium and potassium supplementation as per unit protocol) will be applied.
Alpha Lipoic Acid + Standard Hydration
- Patients will receive the same cisplatin based chemotherapy regimens and standard preventive measures as the control group.
- In addition, they will receive oral alpha lipoic acid at a dose of [e.g., 600 mg] twice daily (ALA [brand/formulation], [manufacturer, country]) starting [e.g., 2 days] before the first cisplatin dose and continued throughout each chemotherapy cycle until 2 days after the last cisplatin administration in that cycle, for a total of 4 cycles
干预措施: Alpha-Lipoic Acid (ALA) (Drug)
结局指标
主要结局
Change in SCr and CrCl in patients receiving Cisplatin Chemotherapy + Alpha-Lipoic Acid compared to Control Group
时间窗: Baseline, weekly up to 6 weeks
Measuring the change in Scr and CrCl in patients before and after they have a cumulative dose of 200mg/m2, depending on each patient's dosage regimen
次要结局
- Patients' Quality of Life(Baseline; and end of study (Up to 6 weeks))
- Incidence of AKI ain patients receiving cisplatin(From cisplatin initiation through end of study (Up to 6 weeks))
- Incidence of cisplatin dose reduction, delay, or discontinuation due to nephrotoxicity(From cisplatin initiation through end of study (Up to 6 weeks))
研究者
Asmaa Bassem Mohammed
Teaching and Research Assistant
Minia University