{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,15]],"date-time":"2026-10-15T12:29:32Z","timestamp":1792067372061,"version":"4.4.0"},"reference-count":34,"publisher":"MDPI AG","issue":"16","license":[{"start":{"date-parts":[[2021,8,9]],"date-time":"2021-08-09T00:00:00Z","timestamp":1628467200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100005010","name":"Associazione Italiana per la Ricerca sul Cancro","doi-asserted-by":"publisher","award":["IG#17736"],"award-info":[{"award-number":["IG#17736"]}],"id":[{"id":"10.13039\/501100005010","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100005010","name":"Associazione Italiana per la Ricerca sul Cancro","doi-asserted-by":"publisher","award":["#22098"],"award-info":[{"award-number":["#22098"]}],"id":[{"id":"10.13039\/501100005010","id-type":"DOI","asserted-by":"publisher"}]},{"name":"5\u00d71000","award":["2014"],"award-info":[{"award-number":["2014"]}]},{"name":"Breast Cancer Research Program (U.S. Department of Defense)","award":["BC161452P1"],"award-info":[{"award-number":["BC161452P1"]}]},{"name":"Associazione Italiana contro le Leucemie-linfomi e Mieloma","award":["-"],"award-info":[{"award-number":["-"]}]},{"DOI":"10.13039\/501100003196","name":"Ministero della Salute","doi-asserted-by":"publisher","award":["PE-2016-02362694"],"award-info":[{"award-number":["PE-2016-02362694"]}],"id":[{"id":"10.13039\/501100003196","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100003196","name":"Ministero della Salute","doi-asserted-by":"publisher","award":["PE-2016-02363073"],"award-info":[{"award-number":["PE-2016-02363073"]}],"id":[{"id":"10.13039\/501100003196","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Cancers"],"abstract":"<jats:p>In preclinical studies, fasting was found to potentiate the effects of several anticancer treatments, and early clinical studies indicated that patients may benefit from regimes of modified fasting. However, concerns remain over possible negative impact on the patients\u2019 nutritional status. We assessed the feasibility and safety of a 5-day \u201cFasting-Mimicking Diet\u201d (FMD) as well as its effects on body composition and circulating growth factors, adipokines and cyto\/chemokines in cancer patients. In this single-arm, phase I\/II clinical trial, patients with solid or hematologic malignancy, low nutritional risk and undergoing active medical treatment received periodic FMD cycles. The body weight, handgrip strength and body composition were monitored throughout the study. Growth factors, adipokines and cyto\/chemokines were assessed by ELISA. Ninety patients were enrolled, and FMD was administered every three weeks\/once a month with an average of 6.3 FMD cycles\/patient. FMD was largely safe with only mild side effects. The patients\u2019 weight and handgrip remained stable, the phase angle and fat-free mass increased, while the fat mass decreased. FMD reduced the serum c-peptide, IGF1, IGFBP3 and leptin levels, while increasing IGFBP1, and these modifications persisted for weeks beyond the FMD period. Thus, periodic FMD cycles are feasible and can be safely combined with standard antineoplastic treatments in cancer patients at low nutritional risk. The FMD resulted in reduced fat mass, insulin production and circulating IGF1 and leptin. This trial was registered on Clinicaltrials.gov in July 2018 with the identifier NCT03595540.<\/jats:p>","DOI":"10.3390\/cancers13164013","type":"journal-article","created":{"date-parts":[[2021,8,9]],"date-time":"2021-08-09T21:41:46Z","timestamp":1628545306000},"page":"4013","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":69,"title":["Safety and Feasibility of Fasting-Mimicking Diet and Effects on Nutritional Status and Circulating Metabolic and Inflammatory Factors in Cancer Patients Undergoing Active Treatment"],"prefix":"10.3390","volume":"13","author":[{"given":"Francesca","family":"Valdemarin","sequence":"first","affiliation":[{"name":"Department of Internal Medicine and Medical Specialties, University of Genoa, 16132 Genoa, Italy"},{"name":"IRCCS Ospedale Policlinico San Martino, 16132 Genoa, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Irene","family":"Caffa","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine and Medical Specialties, University of Genoa, 16132 Genoa, Italy"},{"name":"IRCCS Ospedale Policlinico San Martino, 16132 Genoa, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Angelica","family":"Persia","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine and Medical Specialties, University of Genoa, 16132 Genoa, Italy"},{"name":"IRCCS Ospedale Policlinico San Martino, 16132 Genoa, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anna Laura","family":"Cremonini","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine and Medical Specialties, University of Genoa, 16132 Genoa, Italy"},{"name":"IRCCS Ospedale Policlinico San Martino, 16132 Genoa, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lorenzo","family":"Ferrando","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine and Medical Specialties, University of Genoa, 16132 Genoa, Italy"},{"name":"IRCCS Ospedale Policlinico San Martino, 16132 Genoa, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Luca","family":"Tagliafico","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine and Medical Specialties, University of Genoa, 16132 Genoa, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1736-0697","authenticated-orcid":false,"given":"Alberto","family":"Tagliafico","sequence":"additional","affiliation":[{"name":"IRCCS Ospedale Policlinico San Martino, 16132 Genoa, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1595-2173","authenticated-orcid":false,"given":"Ana","family":"Guijarro","sequence":"additional","affiliation":[{"name":"IRCCS Ospedale Policlinico San Martino, 16132 Genoa, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2957-4078","authenticated-orcid":false,"given":"Federico","family":"Carbone","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine and Medical Specialties, University of Genoa, 16132 Genoa, Italy"},{"name":"IRCCS Ospedale Policlinico San Martino, 16132 Genoa, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4358-6411","authenticated-orcid":false,"given":"Stefano","family":"Ministrini","sequence":"additional","affiliation":[{"name":"Center for Molecular Cardiology, Universit\u00e4t Z\u00fcrich, 8952 Schlieren, Switzerland"},{"name":"Internal Medicine, Angiology and Atherosclerosis, Department of Medicine and Surgery, Universit\u00e0 degli Studi di Perugia, 06129 Perugia, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria","family":"Bertolotto","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine and Medical Specialties, University of Genoa, 16132 Genoa, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pamela","family":"Becherini","sequence":"additional","affiliation":[{"name":"IRCCS Ospedale Policlinico San Martino, 16132 Genoa, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tommaso","family":"Bonfiglio","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine and Medical Specialties, University of Genoa, 16132 Genoa, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chiara","family":"Giannotti","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine and Medical Specialties, University of Genoa, 16132 Genoa, Italy"},{"name":"IRCCS Ospedale Policlinico San Martino, 16132 Genoa, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amr","family":"Khalifa","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine and Medical Specialties, University of Genoa, 16132 Genoa, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Moustafa","family":"Ghanem","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine and Medical Specialties, University of Genoa, 16132 Genoa, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1530-6729","authenticated-orcid":false,"given":"Michele","family":"Cea","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine and Medical Specialties, University of Genoa, 16132 Genoa, Italy"},{"name":"IRCCS Ospedale Policlinico San Martino, 16132 Genoa, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marzia","family":"Sucameli","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine and Medical Specialties, University of Genoa, 16132 Genoa, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Roberto","family":"Murialdo","sequence":"additional","affiliation":[{"name":"IRCCS Ospedale Policlinico San Martino, 16132 Genoa, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Valentina","family":"Barbero","sequence":"additional","affiliation":[{"name":"IRCCS Ospedale Policlinico 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Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1797-5296","authenticated-orcid":false,"given":"Matteo","family":"Lambertini","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine and Medical Specialties, University of Genoa, 16132 Genoa, Italy"},{"name":"IRCCS Ospedale Policlinico San Martino, 16132 Genoa, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Claudio","family":"Vernieri","sequence":"additional","affiliation":[{"name":"IFOM, FIRC Institute of Molecular Oncology, 20139 Milan, Italy"},{"name":"Medical Oncology and Hematology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, 20133 Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1619-1708","authenticated-orcid":false,"given":"Gabriele","family":"Zoppoli","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine and Medical Specialties, University of Genoa, 16132 Genoa, Italy"},{"name":"IRCCS Ospedale Policlinico San Martino, 16132 Genoa, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Valter D.","family":"Longo","sequence":"additional","affiliation":[{"name":"IFOM, FIRC Institute of Molecular Oncology, 20139 Milan, Italy"},{"name":"Longevity Institute and Davis School of Gerontology, University of Southern California, Los Angeles, CA 90089, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0823-8729","authenticated-orcid":false,"given":"Fabrizio","family":"Montecucco","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine and Medical Specialties, University of Genoa, 16132 Genoa, Italy"},{"name":"IRCCS Ospedale Policlinico San Martino, 16132 Genoa, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4194-1547","authenticated-orcid":false,"given":"Samir G.","family":"Sukkar","sequence":"additional","affiliation":[{"name":"IRCCS Ospedale Policlinico San Martino, 16132 Genoa, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alessio","family":"Nencioni","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine and Medical Specialties, University of Genoa, 16132 Genoa, Italy"},{"name":"IRCCS Ospedale Policlinico San Martino, 16132 Genoa, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2021,8,9]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"11820","DOI":"10.18632\/oncotarget.3689","article-title":"Fasting potentiates the anticancer activity of tyrosine kinase inhibitors by strengthening MAPK signaling inhibition","volume":"6","author":"Caffa","year":"2015","journal-title":"Oncotarget"},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"620","DOI":"10.1038\/s41586-020-2502-7","article-title":"Fasting-mimicking diet and hormone therapy induce breast cancer regression","volume":"583","author":"Caffa","year":"2020","journal-title":"Nature"},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"e1657375","DOI":"10.1080\/2162402X.2019.1657375","article-title":"A synergistic triad of chemotherapy, immune checkpoint inhibitors, and caloric restriction mimetics eradicates tumors in mice","volume":"8","author":"Levesque","year":"2019","journal-title":"Oncoimmunology"},{"key":"ref_4","doi-asserted-by":"crossref","first-page":"707","DOI":"10.1038\/s41568-018-0061-0","article-title":"Fasting and cancer: Molecular mechanisms and clinical application","volume":"18","author":"Nencioni","year":"2018","journal-title":"Nat. Rev. Cancer"},{"key":"ref_5","doi-asserted-by":"crossref","first-page":"11806","DOI":"10.18632\/oncotarget.3688","article-title":"Fasting induces anti-Warburg effect that increases respiration but reduces ATP-synthesis to promote apoptosis in colon cancer models","volume":"6","author":"Bianchi","year":"2015","journal-title":"Oncotarget"},{"key":"ref_6","doi-asserted-by":"crossref","first-page":"136","DOI":"10.1016\/j.ccell.2016.06.005","article-title":"Fasting-Mimicking Diet Reduces HO-1 to Promote T Cell-Mediated Tumor Cytotoxicity","volume":"30","author":"Lee","year":"2016","journal-title":"Cancer Cell"},{"key":"ref_7","doi-asserted-by":"crossref","first-page":"124ra27","DOI":"10.1126\/scitranslmed.3003293","article-title":"Fasting cycles retard growth of tumors and sensitize a range of cancer cell types to chemotherapy","volume":"4","author":"Lee","year":"2012","journal-title":"Sci. Transl. Med."},{"key":"ref_8","doi-asserted-by":"crossref","first-page":"147","DOI":"10.1016\/j.ccell.2016.05.016","article-title":"Caloric Restriction Mimetics Enhance Anticancer Immunosurveillance","volume":"30","author":"Pietrocola","year":"2016","journal-title":"Cancer Cell"},{"key":"ref_9","doi-asserted-by":"crossref","unstructured":"Di Biase, S., Shim, H.S., Kim, K.H., Vinciguerra, M., Rappa, F., Wei, M., Brandhorst, S., Cappello, F., Mirzaei, H., and Lee, C. (2017). Fasting regulates EGR1 and protects from glucose- and dexamethasone-dependent sensitization to chemotherapy. PLoS Biol., 15.","DOI":"10.1371\/journal.pbio.1002603"},{"key":"ref_10","doi-asserted-by":"crossref","first-page":"8215","DOI":"10.1073\/pnas.0708100105","article-title":"Starvation-dependent differential stress resistance protects normal but not cancer cells against high-dose chemotherapy","volume":"105","author":"Raffaghello","year":"2008","journal-title":"Proc. Natl. Acad. Sci. 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