Institute of Social Medicine, Epidemiology and Health Economics, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.
Department of Internal and Integrative Medicine, Immanuel Hospital Berlin, Berlin, Germany.
Trials. 2020 Oct 15;21(1):854. doi: 10.1186/s13063-020-04700-9.
BACKGROUND/OBJECTIVES: A few preliminary studies have documented the safety and feasibility of repeated short-term fasting in patients undergoing chemotherapy. However, there is a lack of data from larger randomized trials on the effects of short-term fasting on quality of life, reduction of side effects during chemotherapy, and a possible reduction of tumor progression. Moreover, no data is available on the effectiveness of fasting approaches compared to so-called healthy diets. We aim to investigate whether the potentially beneficial effects of short-term fasting can be confirmed in a larger randomized trial and can compare favorably to a plant-based wholefood diet.
This is a multicenter, randomized, controlled, two-armed interventional study with a parallel group assignment. One hundred fifty patients, including 120 breast cancer patients and 30 patients with ovarian cancer, are to be randomized to one of two nutritional interventions accompanying chemotherapy: (1) repeated short-term fasting with a maximum energy supply of 350-400 kcal on fasting days or (2) repeated short-term normocaloric plant-based diet with restriction of refined carbohydrates. The primary outcome is disease-related quality of life, as assessed by the functional assessment of the chronic illness therapy measurement system. Secondary outcomes include changes in the Hospital Anxiety and Depression Score and as well as frequency and severity of chemotherapy-induced side effects based on the Common Terminology Criteria of Adverse Events. Explorative analysis in a subpopulation will compare histological complete remissions in patients with neoadjuvant treatments.
DISCUSSION/PLANNED OUTCOMES: Preclinical data and a small number of clinical studies suggest that repeated short-term fasting may reduce the side effects of chemotherapy, enhance quality of life, and eventually slow down tumor progression. Experimental research suggests that the effects of fasting may partly be caused by the restriction of animal protein and refined carbohydrates. This study is the first confirmatory, randomized controlled, clinical study, comparing the effects of short-term fasting to a short-term, plant-based, low-sugar diet during chemotherapy on quality of life and histological tumor remission.
ClinicalTrials.gov NCT03162289 . Registered on 22 May 2017.
背景/目的：少数初步研究记录了化疗患者重复短期禁食的安全性和可行性。然而，关于短期禁食对生活质量的影响、化疗期间副作用的减少以及肿瘤进展的可能减少，缺乏来自更大规模随机试验的数据。此外，关于与所谓的健康饮食相比禁食方法的有效性，尚无数据。我们旨在调查短期禁食的潜在有益效果是否可以在更大规模的随机试验中得到证实，并可以与基于植物的全食物饮食相媲美。
这是一项多中心、随机、对照、双臂干预研究，采用平行组分配。将 150 名患者（包括 120 名乳腺癌患者和 30 名卵巢癌患者）随机分为两种伴随化疗的营养干预措施之一：（1）在禁食日进行多次短期禁食，最大能量供应为 350-400kcal；或（2）多次短期限制精制碳水化合物的植物性正常热量饮食。主要结局是使用慢性病治疗评估系统功能评估评估的疾病相关生活质量。次要结局包括根据常见不良事件术语标准评估的焦虑和抑郁量表评分变化以及化疗引起的副作用的频率和严重程度的变化。在亚人群中的探索性分析将比较新辅助治疗患者的组织学完全缓解率。
讨论/计划的结果：临床前数据和少数临床研究表明，重复短期禁食可能会减轻化疗的副作用、提高生活质量，并最终减缓肿瘤进展。实验研究表明，禁食的作用部分可能是由于限制动物蛋白和精制碳水化合物所致。这项研究是第一项比较化疗期间短期禁食与短期植物性低糖饮食对生活质量和组织学肿瘤缓解的确认性、随机对照临床试验。
ClinicalTrials.gov NCT03162289。于 2017 年 5 月 22 日注册。
