Fasting-Mimicking Diet Is Safe and Reshapes Metabolism and Antitumor Immunity in Patients with Cancer
A single-arm trial in 101 patients with cancer receiving standard antitumour therapy.
Cancer Discov, 2022. Vernieri C, et al.
Funding and competing interests (as published with the paper): Authors' DisclosuresC. Vernieri reports grants from AIRC (Associazione Italiana per la Ricerca sul Cancro) during the conduct of the study; in addition, C. Vernieri has a patent for PCT/IB2020/055956 pending and a patent for PCT/IT2020/000083 pending. V. Huber reports grants from Associazione Italiana per la Ricerca sul Cancro (AIRC IG25078) during the conduct of the study. M.C. Garassino reports grants and personal fees from Astra Zeneca, Merck; personal fees from BMS, Roche, Daiichi Sankyo, Celgene, GSK, Eli Lilly, Novartis, and personal fees from Regerenon during the conduct of the study. G. Bianchi reports personal fees from Novartis, Eli Lilly, and personal fees from Roche outside the submitted work. S. Minucci reports a patent for PCT/EP2018/063257 pending. V.D. Longo reports non-financial support and other support from L nutra during the conduct of the study; other support from L nutra outside the submitted work; in addition, V.D. Longo has a patent for several patents related to this topic, but not based on this trial, pending. G. Pruneri reports personal fees from Roche Foundation One, Bayer, Novartis, and personal fees from Lilly outside the submitted work. D. Bedognetti reports grants from Sidra Medicine during the conduct of the study. L. Rivoltini reports grants from Associazione Italiana per la Ricerca sul Cancro (AIRC) (IG-2017 no. 20752) and grants from European Community - Horizon 2020 Precious Grant Agreement number 686089 during the conduct of the study; in addition, L. Rivoltini has a patent for FMD regimen pending. F. de Braud reports a patent for PCT/IB2020/055956 pending and a patent for IT201900009954 pending; and Roche, EMD Serono, NMS Nerviano Medical Science, Sanofi, MSD, Novartis, Incyte, BMS, Menarini Healthcare Research & Pharmacoepidemiology, Merck Group, Pfizer, Servier, AMGEN, Incyte. No disclosures were reported by the other authors.
- Study type
- Human clinical trial (n=101)
- Journal
- Cancer Discov
- Published
- 2022
- Authors
- Vernieri C, et al.
- DOI
- 10.1158/2159-8290.cd-21-0030
- PubMed ID
- 34789537
Summary
The authors ran a clinical trial to examine the safety and biological effects of cyclic 5-day Fasting Mimicking Diet (FMD) alongside standard antitumour therapies in 101 patients with different tumour types. There was no control group. Blood glucose and growth factor concentrations were measured, and the authors carried out integrated transcriptomic and deep-phenotyping analyses of blood and tumour samples.
The authors reported that the diet was safe and feasible in these patients and produced a consistent decrease in blood glucose and growth factor concentrations. They reported changes in immune cell populations, including a contraction of immunosuppressive myeloid and regulatory T-cell compartments in blood, alongside enhanced Th1 and cytotoxic responses within tumours and an enrichment of interferon gamma and other immune signatures. They state that phase II and III trials are needed to investigate whether the diet has antitumour activity or efficacy.
This trial had no control group, and it measured metabolic and immune markers rather than tumour outcomes or survival. The authors state plainly that antitumour efficacy remains to be investigated in later-phase trials. Participants were patients with cancer receiving concurrent standard therapy, not a general wellness population, and the study does not evaluate Prolon directly.
These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.
