NCT04316520已完成不适用
A Pilot Study Evaluating the Tolerability of a Ketogenic Diet With Vitamin Supplementation for Patients Receiving Treatment for Metastatic Renal Cell Carcinoma
University Hospital, Angers1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2020年7月22日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Tolerance of one year of ketogenic diet 2:1
研究概览
简要总结
The purpose of this study is to evaluate the tolerance of one year of ketogenic diet associated with vitamin supplementation in patients treated for a metastatic renal cell carcinoma.
详细描述
This research study is a pilot study evaluating the tolerance of a ketogenic diet associated with a standard of care in patient with metastatic renal cell carcinoma.
The drugs involved in this study could be NIVOLUMAB + IPILIMUMAB, PEMBROLIZUMAB + AXITINIB, SUNITINIB or PAZOPANIB.
Cancer cells are known to have an increased glycolytic activity that allows them to product energy from anaerobic degradation of glucose. A ketogenic diet places the body in ketosis state. It forces the body to burn fat instead of glucose. Fat metabolism occurs via the mitochondrial oxidative phosphorylation. By reducing sugar intake and regulating energy metabolism, the ketogenic diet could contribute to limit tumor progression.
This diet will be introduced during one year, patient will be monitored closely with biological tests and radiological assessments every three month.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Subject with histologically-confirmed renal cell carcinoma
- •At least one CT-verified metastasis ≥ 10 mm, not previously irradiated
- •Treatment : PAZOPANIB, SUNITINIB, PEMBROLIZUMAB/AXITINIB or NIVOLUMAB/IPILIMUMAB (for first line), NIVOLUMAB, CABOZANTINIB, AXITINIB, SORAFENIB, TKI anti-VEGF, other therapy for second and third line of treatment
- •Men and women, aged ≥ 18 years
- •Screening laboratory values must meet the following criteria and should be obtained prior to commencement of treatment:
- •Hemoglobin ≥ 9 g/dL, neutrophils ≥ 1000 /mm3, platelets ≥ 100 000 /mm3, leukocytes ≥ 2000 /mm3
- •Total bilirubin ≤ 1,5 ULN, ASAT and ALAT ≤ 3 x ULN
- •Creatinine clearance ≥ 30 mL/min, verified proteinuria above or equal to 1g/24 hours measured from 24 hours of urine if the urinary protein
- •Corrected calcium ≤ ULN
- •Patient must have signed and dated informed consent
- •Patient must have an internet connection
排除标准
- •Any contraindication to a ketogenic diet : primary carnitine deficiency, fatty acid beta-oxidation and cytogenesis deficiencies, pyruvate carboxylate deficiency, porphyria
- •Swallowing disorder
- •Important surgical procedure within the 4 weeks before treatment
- •Prior radiotherapy must have been completed at least 2 weeks prior to treatment
- •Pregnant women or breastfeeding
- •Subjects with previous malignancies (except non-melanoma skin cancer and the following endometrial in situ cancers) are excluded unless a complete remission was achieved at least 3 years prior to study entry and no additional therapy is required during the study period
- •Subjects with symptomatics brain metastases, uncontrolled compression of the spinal cord, carcinomatous meningitis, signs of cerebral or leptomeningeal involvement
- •Uncontrolled blood pressure (SBP >150 mmH et DBP >100 mmHg)
- •Any serious or uncontrolled medical disorder during the last 6 months : hepatic insufficiency, renal insufficiency, respiratory insufficiency
- •Patients with any severe medical conditions within 6 month prior to inclusion such as : myocardial infarction, severe/instable angina pectoris, coronary artery bypass surgery, NYHA III or IV congestive heart failure, stroke or transient ischemic attack
- •Patients with sere medical conditions within 3 month prior to inclusion such as : grade 3 or grade 4 gastrointestinal bleeding, peptic ulcer treatment resistant, esophagitis or ulcerated gastritis, infectious or inflammatory bowel disease, diverticulitis, thrombosis, pulmonary embolism or other uncontrolled thromboembolic event, unhealed bone fractures
- •Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
- •Malabsorption syndrome
- •Uncontrolled infection
- •QT/QTc interval > 450 msec for men and > 470 msec for women
- •Concomitant treatments : strong inducers of CYP3A4 (DEXAMETHASONE, PHENYTOINE, CARBAMAZEPINE, RIFAMPICINE, RIFABUTINE, RIFAPENTINE, PHENOBARBITAL, and ST. JOHN'S WORT)
- •Social, psychological or medical condition that may interfere with participation in the study or its evaluation
- •Patient deprived of liberty by judicial or administrative decision
- •Patient with psychiatric treatment under duress
- •Patient subject to legal protection measures
- •Patient unable to give informed consent.
结局指标
主要结局
Tolerance of one year of ketogenic diet 2:1
时间窗: 1 year
Frequency of adverse events evaluation
次要结局
- Compliance of ketogenic diet(1 year)
- Overall survival at 2 years(2 years)
- Progression free survival according to RECIST 1.1 at 2 years(2 years)
研究者
研究点 (1)
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