Short-term fasting accompanying chemotherapy as a supportive therapy in gynecological cancer: protocol for a multicenter
- PDF / 715,623 Bytes
- 12 Pages / 595.276 x 790.866 pts Page_size
- 11 Downloads / 150 Views
STUDY PROTOCOL
Open Access
Short-term fasting accompanying chemotherapy as a supportive therapy in gynecological cancer: protocol for a multicenter randomized controlled clinical trial Daniela Koppold-Liebscher1* , Christian S. Kessler1,2, Nico Steckhan1, Vanessa Bähr1, Cornelia Kempter3, Manfred Wischnewsky4, Marisa Hübner1,2, Barbara Kunz1, Marion Paul5, Stefanie Zorn6, Sophia Sari7, Michael Jeitler1,2, Rainer Stange1 and Andreas Michalsen1,2
Abstract Background/objectives: A few preliminary studies have documented the safety and feasibility of repeated shortterm 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. Methods: 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. (Continued on next page)
* Correspondence: [email protected] 1 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 Full list of author information is available at the end of the article © The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If mater
Data Loading...
