Influence of Intermittent Fasting on Locally Advanced Breast Cancer Patients: a Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- pathological response rate
研究概览
简要总结
Breast cancer is the most common cancer type among women in Egypt and world. Preclinical studies show fasting reduces growth factors and modulates nutrient sensing systems, protecting normal cells against chemotherapy. However, cancer cells are not protected due to Differential Stress Resistance (DSR), making them more vulnerable to chemotherapeutics. This study aims to evaluate intermittent fasting impact on neoadjuvant chemotherapy in breast cancer patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients with stage II or III (cT1cN+ or ≥T2 any cN, cM0) breast cancer. - Planned to receive standard neoadjuvant chemotherapy.
- •Measurable disease (breast and/or lymph nodes).
- •WHO performance status 0-
- •Being overweight (BMI: 25-29.9 kg/m2) or obese (BMI: ≥30 kg/m2).
- •Adequate bone marrow function : white blood cells (WBCs) ≥3.0 x 109/l, neutrophils ≥1.5 x 109/l, platelets ≥100 x 109/l
- •Adequate liver function: bilirubin ≤1.5 x upper limit of normal (UNL) range, ALAT and/or ASAT ≤2.5 x UNL, Alkaline Phosphatase ≤5 x UNL
- •Adequate renal function: the calculated creatinine clearance should be ≥50 mL/min
- •Patients must be accessible for treatment and follow-up
排除标准
- •Serious diseases such as recent myocardial infarction, clinical signs of cardiac failure or clinically significant arrhythmias
- •Diabetes Mellitus.
- •Pregnancy or lactating
- •Any metabolic disorders that may affect gluconeogenesis or adaptation to fasting periods.
- •Previous malignancy.
- •Using weight loss medication.
研究组 & 干预措施
Intermittent fasting
16/8 intermittent fasting (limiting foods and calorie-containing beverages to a set window of 8 hours per day) around standard neoadjuvant chemotherapy.
干预措施: intermittent fasting (Other)
regular diet
Regular diet around standard neoadjuvant chemotherapy
结局指标
主要结局
pathological response rate
时间窗: 6months
Assessment of pathological response using the Miller-Payne grading system; it is a grading system from 1-5 with 5 is the best response
次要结局
- Clinical response(6months)
- Long term efficacy of treatment(5 years)
- Body composition changes (fat, muscles, water)(6 months)
- Inflammatory response to chemotherapy.(6 months)
- The percentage of patients with grade III/IV toxicity(6 months)
- Grade I/II side effects of chemotherapy(6 months)
研究者
yostena nagy kamel mekhail
Dr
Menoufia University