Abstract
Background/objectivesA 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.MethodsThis 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 outcomesPreclinical 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.Trial registrationClinicalTrials.gov NCT03162289. Registered on 22 May 2017
Highlights
In recent years, short-term fasting (STF) as a distinct form of caloric restriction has been extensively investigated, in animal experiments, and in some clinical studies
The main objective of this study is to evaluate the effectiveness of the two above supportive dietary interventions in patients with breast cancer or ovarian cancer undergoing chemotherapy
Statistical analysis will be performed using R version 3.5.1 (R Foundation) and IBM SPSS Statistics, version 26.0 (IBM Corp., Armonk, NY, USA). This is the first randomized controlled clinical trial evaluating the effects of intermittent short-term fasting during chemotherapy on Quality of life (QOL) and, in a subpopulation, on histological tumor remission
Summary
Short-term fasting (STF) as a distinct form of caloric restriction has been extensively investigated, in animal experiments, and in some clinical studies. Clinical studies on STF in humans are rare, and different definitions of short-term or intermittent fasting are being used [9,10,11]. There has been no unanimously agreed standard definition of either short-term or intermittent fasting. We use the term STF in our study to define a subtotal caloric restriction of 60–72 h, as we did in a previous publication [12]. In our definition, intermittent fasting differs from STF mainly in its duration
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