Safety and feasibility of fasting‐mimicking diet and effects on nutritional status and circulating metabolic and inflammatory factors in cancer patients undergoing active treatment

Francesca Valdemarin, Irene Caffa, Angelica Persia, Anna Laura Cremonini, Lorenzo Ferrando, Luca Tagliafico, Alberto Tagliafico, Ana Guijarro, Federico Carbone, Stefano Ministrini, Maria Bertolotto, Pamela Becherini, Tommaso Bonfiglio, Chiara Giannotti, Amr Khalifa, Moustafa Ghanem, Michele Cea, Marzia Sucameli, Roberto Murialdo, Valentina BarberoRaffaella Gradaschi, Francesca Bruzzone, Consuelo Borgarelli, Matteo Lambertini, Claudio Vernieri, Gabriele Zoppoli, Valter D. Longo, Fabrizio Montecucco, Samir G. Sukkar, Alessio Nencioni

Research output: Contribution to journalArticlepeer-review

Abstract

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’ nutritional status. We assessed the feasibility and safety of a 5‐day “Fasting‐Mimicking Diet” (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’ 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.

Original languageEnglish
Article number4013
JournalCancers
Volume13
Issue number16
DOIs
Publication statusPublished - Aug 2 2021

Keywords

  • Body composition
  • Cancer metabolism
  • Circulating growth factors
  • Feasibility
  • Modified fasting
  • Safety

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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