Clinical Study on the Efficacy of Fasting and Nutritional Therapy as a Complementary Treatment of Advanced Metastatic Prostate Cancer Undergoing Chemotherapy - an Exploratory Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- FACT-P/-Taxane/-An sum score
研究概览
简要总结
The aim of this trial is a first evaluation of the effectiveness of intermittent fasting as a supplementary therapy in patients with CRPC or hormone-sensitive prostate cancer with high metastatic load (1≥ visceral and ≥4 osseous metastases) in respect to quality of life, reduction of side effects and possible reduction in tumor progression.
详细描述
Prostate cancer is in Germany with approximately 25% of all cancers the most common cancer among man. Assumably there will be an increase in prostate cancer in the next few years because of demographic factors. The progressive metastatic prostate cancer often develops an androgen resistance. This so-called Castration-Resistant Prostate Cancer (CRPC) is not responsive to androgen deprivation therapy. Depending on symptoms and progression first-line chemotherapy - docetaxel and abiraterone are available.
Intermittent fasting as a form of caloric restriction has been studied most extensively experimentally in recent years. It showed consistent beneficial effects on relevant inflammatory and oncological pathways. In the field of preclinical oncology research groups have recently focused on intermittent fasting with chemotherapeutic treatment and promising experimental data have been published. In summary, the combination of fasting and chemotherapy was more effective in various cancer animal models than chemotherapy alone.
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
- 25 Years 至 89 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of CRPC or hormone-sensitive prostate cancer with high metastatic load
- •Cancer is treated to guidelines conventionally with chemotherapy or with a combination of hormone therapy and chemotherapy.
排除标准
- •Underweight (BMI <20 kg/m2) or actual weight decrease >2 kg or >5 kg in the last 1 or 3 months.
- •Eating disorder
- •Psychosis
- •Terminal illness with a significant limitation of mobility and overall vitality
- •Diabetes mellitus type 1
- •Renal insufficiency stage > 2, GFR <60mlmin / 1.73 m2
研究组 & 干预措施
Fasting
60h-modified fasting (36h before and 24h after chemotherapy)
干预措施: Fasting (Other)
Control
mediterranean diet
干预措施: Control (Other)
结局指标
主要结局
FACT-P/-Taxane/-An sum score
时间窗: Assessment day 0 (baseline) and 7 days after each of 6 chemotherapies (study weeks 1,4,7,10,13,16)
summarized change of FACT score from baseline to day 8 after each chemotherapy
次要结局
- FACT-P/-Taxane/-An sum score(Assessment day 0 (baseline) and 3 and 6 months after day 0)
- HADS(Assessment day 0 (baseline) and 7 days after each of 6 chemotherapies (study weeks 1,4,7,10,13,16) and after 3 and 6 months after study day 0)
研究者
Andreas Michalsen
Prof. Dr.
Charite University, Berlin, Germany