A Pilot, Feasibility Study of Intermittent Caloric Restriction Plus Plant-based Protein Diet in Cancer Patients Receiving Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- The feasibility of intermittent caloric restriction plus a plant-based diet in cancer patients receiving chemotherapy
研究概览
简要总结
Caloric restriction may alter the response to chemotherapy induced stress response and enhance its antitumor effect. This study intends to use an intermitted caloric restriction protocol with alternate days before the chemotherapy administration to enhance the cytotoxic effect generated by standard treatment of cancer.
详细描述
This pilot trial will provide preliminary evidence that 1) intermittent caloric restriction and a plant-based diet is feasible in cancer patients; 2) intermittent caloric restriction and a plant-based diet can be safely combined with standard chemotherapy; and 3) intermittent caloric restriction and a plant-based diet may reduce the side effects but increase the antitumor effects of standard chemotherapy.
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
- •• Histologically documented, cancer patients who are eligible to receive cytotoxic chemotherapy.
- •Life expectancy of at least 6 months
- •Adults ≥ 18 years of age
- •Adequate hematologic, renal, and liver function as evidenced by the following:
- •White blood cell (WBC) ≥ 2,500 cells/μL
- •Absolute neutrophil count (ANC) ≥ 1,000 cells/μL
- •Platelet Count ≥ 100,000 cells/μL
- •Hemoglobin (HgB) ≥ 9.0 g/dL
- •Creatinine ≤ 2.0 mg/dL
- •Total bilirubin ≤ 2 x upper limit of normal (ULN)
- •Aspartate aminotransaminase (AST, SGOT) ≤ 2.5 x ULN
- •Alanine aminotransaminase (ALT, SGPT) ≤ 2.5 x ULN
排除标准
- •• Eastern Cooperative Oncology Group (ECOG) performance status 2 or higher
- •Treatment with any of the following medications or interventions within 28 days of registration:
- •Systemic corticosteroids; however, use of inhaled, intranasal, and topical steroids is acceptable.
- •High dose calcitriol [1,25(OH)2VitD] (i.e., > 7.0 μg/week)
- •Any infection requiring parenteral antibiotic therapy or causing fever (temperature > 100.5°F or 38.1°C) within 1 week prior to registration
- •A known allergy, intolerance, or medical contraindication to receiving the contrast dye required for the protocol-specified CT/MRI imaging
- •Any medical intervention or other condition which, in the opinion of the Principal Investigator, could compromise adherence with study requirements or otherwise compromise the study's objectives
结局指标
主要结局
The feasibility of intermittent caloric restriction plus a plant-based diet in cancer patients receiving chemotherapy
时间窗: 12 Months
enrollment rate
次要结局
- To obtain preliminary evidence of clinical efficacy of the combination of chemotherapy and intermittent caloric restriction(12 Months)
研究者
Roberto Pili
Associate Dean for Cancer Research and Integrative Oncology
State University of New York at Buffalo