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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., Competing Interests: MB reports honoraria and expenses from Pharma Mar AG, Astra Zeneca, TesaroBio GmbH, GSK, Roche, Clovis Oncology and consultant activity to AstraZeneca, Clovis Oncology, Eisai, GSK, MSD, PharmaMar, Roche and Tesaro Bio GmbH. Furthermore, he has received research funding by AstraZeneca, Clovis Oncology, MSD, Eisai and Novartis. None were related to this study. MS reports personal fees from AstraZeneca, BioNTech, Eisai, Lilly, MSD, Novartis, Pantarhei Bioscience, Pfizer, Roche, and SeaGen outside the submitted work. Institutional research funding from AstraZeneca, BioNTech, Eisai, Genentech, German Breast Group, Novartis, Palleos, Pantarhei Bioscience, Pierre-Fabre, and Roche. Travel reimbursement from Pfizer and Roche. In addition, M.S. has a patent for EP 2390370 B1 issued and a patent for EP 2951317 B1 issued. AH reports honoraria and expenses from AstraZeneca, Celgen, Leo Pharma, MedConcept GmbH, Med update GmbH, Medpublico GmbH, Pfizer, PharmaMar GmbH, Pierre Fabre Pharma GmbH, Roche Pharma AG, Tesaro Bio Germany GmbH as well as work as a consultant to MSD SHARP & DOHME GmbH, PharmaMar, Medpublico GmbH, Pierre Fabre Pharma GmbH, Roche Pharma AG and Tesaro Bio Germany GmbH. None were related to this study. RS reports honoraria and expenses from Roche Pharma AG and AstraZeneca GmbH. SS reports honoraria from Lilly, Eisai, and Pfizer as well as expenses from Kite Gilead, all outside of this trial. KAn reports paid lectures by Clovis Oncology, AstraZeneca, Pharma Mar, MSD and Eisai not related to this trial. KAl received speaker honoraria from Roche Pharma AG, Pfizer Pharma GmbH, Seagen, Med publico GmbH and AstraZeneca not related to the current work. All author authors report no conflict of interest. BB-S reports honoraria from Seagen and MSD not related to this trial. ALe reports honoraria from Astra Zeneca and Roche not related to this trial. SK received speaker honoraria from Roche Pharma AG and Novartis Pharma GmbH Germany, research funding from Novartis Pharma GmbH Germany and travel reimbursement from PharmaMar and Novartis Pharma GmbH Germany, non-related to this trial. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (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.)

Introduction: Perioperative red blood cell (RBC) transfusions have been associated with increased morbidity and worse oncological outcome in some solid neoplasms. In order to elucidate whether RBC transfusions themselves, the preoperative anemia of cancer (AOC), or the impaired global health status might explain this impact on patients with endometrial cancer (EC) or ovarian cancer (OC), we performed a retrospective, single-institution cohort study., Materials and Methods: Women older than 60 years with EC or OC were included. The influence of RBC transfusions, AOC, and frailty status determined by the G8 geriatric screening tool (G8 score), as well as the clinical-pathological cancer characteristics on progression-free survival (PFS) and overall survival (OS), was determined by using the Kaplan-Meier method and the Cox regression analyses., Results: In total, 263 patients with EC (n = 152) and OC (n = 111) were included in the study. Patients with EC receiving RBC transfusions were faced with a significantly shorter 5-year PFS (79.8% vs. 26.0%; p < 0.001) and 5-year OS (82.6% vs. 25.7%; p < 0.001). In multivariable analyses, besides established clinical-pathological cancer characteristics, the RBC transfusions remained the only significant prognostic parameter for PFS (HR: 1.76; 95%-CI [1.01-3.07]) and OS (HR: 2.38; 95%-CI [1.50-3.78]). In OC, the G8 score stratified the cohort in terms of PFS rates (G8-non-frail 53.4% vs. G8-frail 16.7%; p = 0.010) and AOC stratified the cohort for 5-year OS estimates (non-anemic: 36.7% vs. anemic: 10.6%; p = 0.008). Multivariable Cox regression analyses determined the G8 score and FIGO stage as independent prognostic factors in terms of PFS (HR: 2.23; 95%-CI [1.16-4.32] and HR: 6.52; 95%-CI [1.51-28.07], respectively). For OS, only the TNM tumor stage retained independent significance (HR: 3.75; 95%-CI [1.87-7.53])., Discussion: The results of this trial demonstrate the negative impact of RBC transfusions on the prognosis of patients with EC. Contrastingly, the prognosis of OC is altered by the preoperative global health status rather than AOC or RBC transfusions. In summary, we suggested a cumulatively restrictive transfusion management in G8-non-frail EC patients and postulated a more moderate transfusion management based on the treatment of symptomatic anemia without survival deficits in OC patients., Competing Interests: KA reports personal fees from Eisai, Roche, MSD. MWS reports holding a patent WO 2021/176091 A1 not related to this study. SK received speaker Honoria, research funding and travek reimbursement from Vovartis Pharma GmbH Germany. MS reports personal fees from AstraZeneca, BioNTech, Daiichi Sankyo, Eisai, Lilly, MSD, Novartis, Pantarhei Bioscience, Pfizer, Roche, and SeaGen outside the submitted work. Institutional research funding from AstraZeneca, BioNTech, Eisai, Genentech, German Breast Group, Novartis, Palleos, Pantarhei Bioscience, Pierre Fabre, and SeaGen. In addition, MS has a patent for EP 2390370 B1 and a patent for EP 2951317 B1issued. RS reports honoraria and expenses from Roche Pharma AG and AstraZeneca GmbH. AH reports honoraria and expenses from AstraZeneca, FBA Frauenärzte BundesAkademie GmbH, KlarigoVerlag, MedConcept, Med public GmbH, Med update GmbH, Medicultus, Pfizer, Promedicis GmbH, Pierre Fabre Pharma GmbH, Softconsult, Roche Pharma AG, Streamedup! GmbH, Tesaro Bio Germany GmbH. I am consultant to PharmaMar, Promedicis GmbH, Pierre Fabre Pharma GmbH, Roche Pharma AG and Tesaro Bio Germany GmbH. I have received funded research from Celgene. MB reports honoraria and expenses from Pharma Mar, Astra Zeneca, Tesaro, GSK, Roche, Clovis Oncology. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Anic, Schmidt, Schmidt, Krajnak, Löwe, Linz, Schwab, Weikel, Brenner, Westphalen, Rissel, Hartmann, Conradi, Hasenburg and Battista.)