Kurzzeitiges Fasten bei Chemotherapie als unterstützende Therapie bei gynäkologischem Krebs: Protokoll für eine multizentrische randomisierte kontrollierte klinische Studie

Titel der Studie: Short-term fasting accompanying chemotherapy as a supportive therapy in gynecological cancer: protocol for a multicenter randomized controlled clinical
von Koppold-Liebscher D, Kessler CS, Steckhan N, Bähr V, Kempter C, Wischnewsky M, Hübner M, Kunz B, Paul M, Zorn S, Sari S, Jeitler M, Stange R, Michalsen A. (2020)

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.

Präklinische Daten und eine kleine Anzahl klinischer Studien legen nahe, dass wiederholtes kurzfristiges Fasten die Nebenwirkungen einer Chemotherapie verringern, die Lebensqualität verbessern und schließlich das Fortschreiten des Tumors verlangsamen kann. Experimentelle Untersuchungen legen nahe, dass die Auswirkungen des Fastens teilweise durch die Einschränkung von tierischem Protein und raffinierten Kohlenhydraten verursacht werden können. Diese Studie ist die erste bestätigende, randomisierte, kontrollierte klinische Studie, in der die Auswirkungen des kurzfristigen Fastens mit einer kurzfristigen, zuckerarmen Diät auf pflanzlicher Basis während der Chemotherapie auf die Lebensqualität und die histologische Tumorremission verglichen werden.

Vollständiger Beitrag: https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-020-04700-9

Short-term fasting accompanying chemotherapy as a supportive therapy in gynecological cancer: protocol for a multicenter randomized controlled clinical trial. Trials. 2020 Oct 15;21(1):854. doi: 10.1186/s13063-020-04700-9. PMID: 33059765; PMCID: PMC7559781.