Effects of Short-term Fasting on Tolerance to Adjuvant Chemotherapy in Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- chemotherapy-induced neutropenia
研究概览
简要总结
The purpose of this study is to determine the effect of short-term fasting on tolerance to adjuvant chemotherapy in breast cancer patients
详细描述
Evidence from experimental animals provides strong support for the concept that caloric restriction (CR) increases resistance to multiple forms of stress. CR decreases plasma levels of growth factors, e.g. insulin-like growth factor-I (IGF-I), thereby diverting energy from growth to maintenance. Accordingly, the currently available information suggests that short-term fasting protects normal cells against the perils of (high dose) chemotherapy. In contrast, cancer cells are not (or less) protected as a result of their self-sufficiency in growth signals. This phenomenon is termed Differential Stress Resistance (DSR). DSR reduces the severity of side-effects caused by the toxicity of chemotherapy, without interfering with its effect on reduction of tumour volume or tumour markers. A recent report, sketching a case series of 10 cancer patients, suggests that short term fasting protects against the side effects of chemotherapy in humans. Indeed, the majority of patients preferred fasting over feeding in preparation of their therapy. This study aims to further evaluate the impact of fasting on tolerance to chemotherapy in humans.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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 breast cancer patients, receiving adjuvant TAC-chemotherapy
- •Age ≥ 18 years old
- •WHO performance status 0-2
- •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
- •Survival expectation > 3 months
- •Patients must be accessible for treatment and follow-up
- •Written informed consent according to the local Ethics Committee requirements
排除标准
- •Serious other diseases such as recent myocardial infarction, clinical signs of cardiac failure or clinically significant arrhythmias
- •Diabetes Mellitus
- •body mass index (BMI) < 19 kg/m2
- •Pregnancy or lactating
- •Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent
研究组 & 干预措施
Short-term fasting
short term fasting (i.e. 24 hours before and 24 hours after administration of chemotherapy) in 20 breast cancer patients
干预措施: Short-term fasting (Other)
Healthy nutrition
20 breast cancer patients eat according to the current guidelines for healthy nutrition as from 24 hours before until 24 hours after the beginning of administration of chemotherapy.
干预措施: Healthy nutrition (Other)
结局指标
主要结局
chemotherapy-induced neutropenia
时间窗: approximately 126 days
Neutrophil count after 6 cycles of chemotherapy (6x 21 days)
次要结局
- chemotherapy-induced DNA damage in leukocytes(21 days)
- effect of short-term fasting on the body's inflammatory response to chemotherapy(21 days)
- perceived side effects of chemotherapy(21 days)
研究者
Hanno Pijl
Prof. dr. H. Pijl
Leiden University Medical Center