Effects of intermittent fasting on quality of life tolerance of chemotherapy in patients with gynecological cancers: study protocol of a randomized-controlled multi-center trial

Mona Wanda Schmidt; Walburgis Brenner; Susanne Gebhard; Marcus Schmidt; Susanne Singer; Lina Weidenbach; Harriett Hahn; Diana Puzankova; Bettina Blau-Schneider; Antje Lehnert; Marco Johannes Battista; Katrin Almstedt; Anja Lütkemeyer; Markus Philipp Radsak; Aline Mähringer-Kunz; Slavomir Krajnak; Valerie Cathrine Linz; Roxana Schwab; Boris Gabriel; Annette Hasenburg; Katharina Anic

doi:10.3389/fonc.2023.1222573

Effects of intermittent fasting on quality of life tolerance of chemotherapy in patients with gynecological cancers: study protocol of a randomized-controlled multi-center trial

Front Oncol. 2023 Jul 19:13:1222573. doi: 10.3389/fonc.2023.1222573. eCollection 2023.

Authors

Mona Wanda Schmidt¹, Walburgis Brenner², Susanne Gebhard², Marcus Schmidt¹, Susanne Singer³, Lina Weidenbach¹, Harriett Hahn¹, Diana Puzankova¹, Bettina Blau-Schneider⁴, Antje Lehnert⁴, Marco Johannes Battista¹, Katrin Almstedt¹, Anja Lütkemeyer¹, Markus Philipp Radsak⁵, Aline Mähringer-Kunz⁶, Slavomir Krajnak¹, Valerie Cathrine Linz¹, Roxana Schwab¹, Boris Gabriel³, Annette Hasenburg¹, Katharina Anic¹

Affiliations

¹ Department of Gynecology and Obstetrics, University Medical Center of Johannes Gutenberg University of Mainz, Mainz, Germany.
² Department of Gynecology and Obstetrics, Management of the Scientific laboratories, University Medical Center of Johannes Gutenberg University of Mainz, Mainz, Germany.
³ Division of Epidemiology and Health Services Research, Institute of Medical Biostatistics, Epidemiology and Informatics (IMBEI), University Medical Center of Johannes Gutenberg University of Mainz, Mainz, Germany.
⁴ Department of Obstetrics and Gynecology, St. Josefs Hospital Wiesbaden Academic Teaching Hospital, Wiesbaden, Germany.
⁵ IIIrd Department of Medicine, Medical Center of the Johannes Gutenberg-University of Mainz, Mainz, Germany.
⁶ Department of Radiology, University Medical Center of Johannes Gutenberg University of Mainz, Mainz, Germany.

Abstract

Fatigue is a very common side effect during intravenous chemotherapy. Unfortunately, only few effective therapeutic options are available, mostly based on daily activity. In our pilot trial we were able to demonstrate that intermittent fasting can reduce fatigue in healthy people, thus we aimed to assess the effects of the fasting dietary on quality of life during chemotherapy in patients with gynecological cancer, especially on the domain of fatigue. The IFAST trial is designed as a prospective, randomized-controlled, multi-center trial. Participation will be offered to women with gynecological cancers (breast cancer, ovarian cancer including peritoneal and fallopian tube cancers, endometrial cancer and cervical cancer) who are planned to receive intravenous chemotherapy for at least three months. Eligible patients will be randomized 1:1, stratified by tumor type and study center. Primary endpoint is the difference in mean change in fatigue, assessed with the Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT- FS^©). Exploratory secondary endpoints will include general Quality of Life impairment, tolerance of chemotherapy, immunological changes, peripheral cell damage in blood cells, as well as tumor response to chemotherapy. There is new evidence that prolonged fasting periods of 46-96 hours during chemotherapy can positively influence the quality of life during chemotherapy. However, these fasting regiments are not feasible for many patients. Intermittent fasting could be a feasible (manageable) option for many patients to actively improve their quality of life and tolerance to chemotherapy and possibly even enhance the effectiveness of chemotherapy.

Trial registration: https://drks.de, identifier DRKS00031429.

Keywords: chemotherapy; fatigue; gynecological cancers; intermittent fasting; quality of life.

Copyright © 2023 Schmidt, Brenner, Gebhard, Schmidt, Singer, Weidenbach, Hahn, Puzankova, Blau-Schneider, Lehnert, Battista, Almstedt, Lütkemeyer, Radsak, Mähringer-Kunz, Krajnak, Linz, Schwab, Gabriel, Hasenburg and Anic.

Grants and funding

The research is supported by funding of the University Medical Center Mainz. The sponsors had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript nor do they have ultimate authority over any of these actions.