A randomized clinical trial to assess the nephroprotective efficacy of renogrit in patients receiving Cisplatin based chemotherapy in advanced or metastatic solid tumors.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- To demonstrate the efficacy of Renogrit in the prevention of cisplatin induced nephrotoxicity
研究概览
简要总结
Chemotherapy is an integral part of cancer treatment. Cisplatin is one of the most effective chemotherapeutic agents, widely used for the treatment of several malignant solid tumors. However, its clinical use is limited due to the severe side effects, including nephrotoxicity and acute kidney injury. This study will help to determine whether the addition of renogrit to cisplatin-based chemotherapy will reduce the nephrotoxicity and improve quality of life. The study will be done in 2 cancer types namely head and neck cancer and lung cancer, as these are commonly treated with cisplatin-based chemotherapy. The study is based on the clinical experience of several ayurvedic practitioners all over India who have used Renogrit for renal disorders, chronic kidney disease, and it also supports and maintains renal health. A total of 220 participants will be enrolled for this study for a period of 2 years which aims to compare the nephroprotective effect in the presence and absence of renogrit. It is an interventional study with 50% patients on standard arm receiving cisplatin based chemotherapy and another 50% patients on interventionl arm receiving cisplatin based chemotherapy with renogrit tablets. This study involved PK bloos sampling at specified time points. FACT-G quality of life questionnaire will be administered to patients on both arms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with evaluable disease, histologically documented confirmed diagnosis of solid malignancy of head and neck, lung and esophagus.
- •All patients planned for single agent cisplatin or its combination based chemotherapy at dose more than or equal to 75 mg/m2
- •ECOG performance status less than equal to 2
- •Patients who are administered only a full dose of cisplatin that is more than or equal to 75mg/m
- •Voluntarily signed informed consent.
- •Patient is ablee to swallow oral medication.
排除标准
- •Diagnosis of chronic kidney disease (CKD) at baseline (glomerular filtration rate less than 60 mL/min/1.73m2 determined by Cockcorft-gault equation.
- •Past kidney transplant patients.
- •Previous use of any nephrotoxic drugs (e.g. aminoglycoside antibiotics, NSAIDs and any other drug which is potentially nephrotoxic including complementary alternative medicines) in the two weeks prior to initiation of Cisplatin (CisP) treatment.
- •Previous hematopoietic stem cell transplant
- •Any chronic or acute health condition that the investigator feels would render the patient inappropriate for this study, including but not limited to significant uncontrolled cardiorespiratory, hepatic, infectious, or renal disease at the discretion of the investigator
- •History hypersensitivity reaction (anaphylaxis, angioedema, exfoliated skin conditions).
- •Patients who receive fractionated dose of cisplatin will not be included in the study.
- •Patients requiring dose modification of cisplatin for any underlying condition.
- •Previous use of Cisplatin (CisP) based chemotherapy.
结局指标
主要结局
To demonstrate the efficacy of Renogrit in the prevention of cisplatin induced nephrotoxicity
时间窗: Baseline, Cycle 1 Day 1 and 1 year after chemotherapy treatment.
次要结局
- 1. To demonstrate the efficacy of Renogrit over standard supportive care in preventing deterioration of(markers of kidney function (eGFR and serum NGAL))
研究者
Dr Vikram Gota
ACTREC, Tata Memorial Centre