Schmidt Mona Wanda, Brenner Walburgis, Gebhard Susanne, Schmidt Marcus, Singer Susanne, Weidenbach Lina, Hahn Harriett, Puzankova Diana, Blau-Schneider Bettina, Lehnert Antje, Battista Marco Johannes, Almstedt Katrin, Lütkemeyer Anja, Radsak Markus Philipp, Mähringer-Kunz Aline, Krajnak Slavomir, Linz Valerie Cathrine, Schwab Roxana, Gabriel Boris, Hasenburg Annette, Anic Katharina
Department of Gynecology and Obstetrics, University Medical Center of Johannes Gutenberg University of Mainz, Mainz, Germany.
Department of Gynecology and Obstetrics, Management of the Scientific laboratories, University Medical Center of Johannes Gutenberg University of Mainz, Mainz, Germany.
Front Oncol. 2023 Jul 19;13:1222573. doi: 10.3389/fonc.2023.1222573. eCollection 2023.
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.
https://drks.de, identifier DRKS00031429.
疲劳是静脉化疗期间非常常见的副作用。不幸的是，有效的治疗选择很少，大多基于日常活动。在我们的试点试验中，我们能够证明间歇性禁食可以减轻健康人的疲劳，因此我们旨在评估禁食饮食对妇科癌症患者化疗期间生活质量的影响，尤其是对疲劳方面的影响。IFAST试验设计为一项前瞻性、随机对照、多中心试验。将邀请计划接受至少三个月静脉化疗的妇科癌症（乳腺癌、卵巢癌包括腹膜和输卵管癌、子宫内膜癌和宫颈癌）女性参与。符合条件的患者将按肿瘤类型和研究中心进行1:1随机分层。主要终点是用慢性病治疗功能评估-疲劳量表（FACIT-FS）评估的疲劳平均变化差异。探索性次要终点将包括总体生活质量损害、化疗耐受性、免疫变化、血细胞外周细胞损伤以及肿瘤对化疗的反应。有新证据表明化疗期间46至96小时的长时间禁食可对化疗期间的生活质量产生积极影响。然而，这些禁食方案对许多患者来说并不可行。间歇性禁食可能是许多患者积极改善生活质量和化疗耐受性甚至可能提高化疗效果的可行（可管理）选择。
