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临床试验 NCT07476443 (VitC-CoQ10) 针对肾毒性目前尚未招募。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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艾因夏姆斯大学Renoprotective Role of Vitamin C and Coenzyme Q10 in Nephrotoxicity (VitC-CoQ10) II期, III期 75
临床试验详情主要以英语提供。然而，试验雷达 AI可以提供帮助！只需点击“试验详解”即可查看和讨论您选择的语言的试验信息。
临床试验NCT07476443 (VitC-CoQ10)旨在研究预防，主要针对肾毒性。这是一项II期 III期 干预性研究试验，当前状态为尚未招募。试验尚未开始，计划于2026年4月20日开始，预计招募75名患者。该研究由艾因夏姆斯大学主导，计划于2027年8月20日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2026年3月17日。
简要概括
Cisplatin is a widely used chemotherapy drug for many solid tumors (e.g., lung, bladder, ovarian, head and neck cancers). Despite its efficacy, its clinical use is limited by severe side effects, mainly nephrotoxicity, which occurs in ~30% of patients after treatment. Once inside cells, cisplatin undergoes activation, leading to DNA and mitochondrial damage, oxidative stress, inflammation, apoptosis, and eventual ac...显示更多
详细描述
Cisplatin is a widely used chemotherapeutic agent in the treatment of several solid tumors; however, its clinical use is limited by nephrotoxicity, which occurs in a significant proportion of patients. Cisplatin-induced renal injury is primarily associated with oxidative stress, inflammation, and mitochondrial dysfunction leading to tubular cell damage.
Vitamin C is a potent antioxidant that scavenges reactive oxyge...
显示更多官方标题
The Potential Renoprotective Effect of Vitamin c and Coenzyme q10 Against Cisplatin Induced Nephrotoxicity in Cancer Patients
疾病
肾毒性出版物
关于此临床试验发表的科学文章和研究论文：其他研究标识符
- VitC-CoQ10
- 2020110301
NCT编号
实际开始日期
2026-04-20
最近更新发布
2026-03-17
预计完成日期
2027-08-20
计划入组人数
75
研究类型
干预性研究
试验分期 (阶段)
II期
III期
III期
试验状态
尚未招募
关键词
Cisplatin
Vitamin C
CoQ10
cancer
nephrotoxicity
KIM-1
Vitamin C
CoQ10
cancer
nephrotoxicity
KIM-1
主要目的
预防
分配方式
随机
干预模型
平行
盲法
无（开放性试验）
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
无干预control 25 patients will receive only the standard of care as the chemotherapy regimen consists of ; cisplatin+gemcitabine. | 不适用 |
阳性对照Vit C 25 patients will receive Vitamin C 500 mg administered orally once daily for 10 days. (for 2 days before day 1 for each cycle ). | Vitamin C Vitamin C 500 mg administered orally |
阳性对照CoQ10 25 patients will receive Coenzyme q10 30 mg administered orally once daily for 10 days. (for 2 days before day 1 for each cycle ). | Coenzyme Q 10 30 mg administered orally |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Evaluation of the potential protective effects of Vitamin C and Coenzyme Q10 against cisplatin-induced nephrotoxicity in chemotherapy-naïve cancer patients. | The Incidence and severity of nephrotoxicity is the main outcome as The assessment based on serum creatinine elevation and Graded according to CTCAE version 5.0 Unit of Measure: CTCAE grade | 3 cycles (21 days each). |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
KIM-1 biomarker levels | As an early indicator of acute cisplatin induced kidney injury. | 3 cycles (21 days each). |
Assesment of the quality of life | Assesment of the quality of life through The European Organisation for Research and Treatment of Cancer (EORTC QLQ-C30) questionnaire as it consists of 30 items that assess five functional domains, three symptom domains, a global health status/quality-of-life scale and each item is scored on a 4-point Likert scale:1 for Not at all and 4 for Very much, but the global health status items are scored on a 7-point scale ranging from very poor to excellent.
Scores are linearly transformed to a 0-100 scale:
Higher functional scores = better functioning / better QoL Higher symptom scores = greater symptom burden | 3 cycles (21 days each) and it will be measured by the end of the third cycle |
参与助手
资格标准
适龄参与研究
成人, 老年人
最低年龄要求
18 Years
适龄性别
全部
- Chemotherapy-naïve patients diagnosed with different types of cancer.
- Age :adult patients (aged 18-65 years)
- Candidates eligible for induction chemotherapy (cisplatin+gemcitabine). Baseline (eGFR) ≥60 ml/min/1.73 m².
- Eastern Cooperative Oncology Group (ECOG) performance status <2.
- Hematologic parameters (WBC count ≥ 3,000/mm³ -- Platelet count ≥ 75,000/mm³-- Hb level ≥ 8.0 g/dL)
- Alanine aminotransferase (ALT) ≤3×(ULN).
- Prior chemotherapy.
- Uncontrolled Diabetes mellitus, active infection, heart failure, liver impairment, gastritis or G-6-P) deficiency.
- History of nephrotoxic drugs use over the past 3 months prior to recruitment (e.g., aminoglycosides, amphotericin B, or vancomycin).
- Known allergy to any of the study drugs.
艾因夏姆斯大学研究责任方
ghada saeid, 主要研究者, Principal Investigator, Ain Shams University
研究中心联系人
联系人: Ghada S Elseidy, Master, 01124006769, [email protected]
联系人: Rana S Fouad, PHD, 01208164247, [email protected]
1 位于 1 个国家/地区的研究中心
Shoubra
Nasser Institute for Research and Treatment, Cairo, Shoubra, 11617, Egypt
Rasha M AbdelMotagalee, Senior, 联系人, 01067366826, [email protected]
Mohammed H, 联系人, 01002406744
Rasha M AbdelMotagalee, Consultant, 主要研究者