Short-term fasting accompanying chemotherapy as a supportive therapy in gynecological cancer: protocol for a multicenter randomized controlled clinical trial

Trials

Cornelia Kempter¹  Manfred Wischnewsky²  Stefanie Zorn³  Sophia Sari⁴  Barbara Kunz⁵  Daniela Koppold-Liebscher⁵  Nico Steckhan⁵  Vanessa Bähr⁵  Rainer Stange⁵  Michael Jeitler⁶  Marisa Hübner⁶  Andreas Michalsen⁶  Christian S. Kessler⁶  Marion Paul⁷ 

[1] Department of Gynecology, Waldfriede Hospital, Berlin, Germany;Department of Mathematics and Computer Science, University of Bremen, Bremen, Germany;Department of Medicine I, Section of Clinical Nutrition and Dietetics, Medical Center – University of Freiburg, Freiburg im Breisgau, Germany;Department of Nutrition, Technische Universität München, Munich, Germany;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;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;Vivantes Hospital Breast Centre, Berlin, Germany;

关键词: Breast cancer;    Ovarian cancer chemotherapy;    Short-term fasting;    Intermittent fasting;    Plant-based nutrition;    Caloric restriction;    Randomized controlled trial;   

DOI  :  10.1186/s13063-020-04700-9

来源: Springer

【 摘 要 】

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

【 授权许可】

CC BY