NCT03340935

Safety, Feasibility and Metabolic Effects of the Fasting Mimicking Diet (FMD) in Cancer Patients

Completed NA Last updated 4 August 2020

What this trial tests

NA trial testing Fasting mimicking diet in Malignant Neoplasm in 101 participants. Completed in 31 July 2020.

Timeline

1 February 2017

Primary endpoint
30 July 2020

31 July 2020

Quick facts

Lead sponsor	Filippo de Braud
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	101
Start date	1 February 2017
Primary completion	30 July 2020
Estimated completion	31 July 2020
Sites	1 location across Italy

Drugs / interventions tested

• Fasting mimicking diet

Conditions studied

• Malignant Neoplasm — all drugs for Malignant Neoplasm →
• Cancer — all drugs for Cancer →

Sponsor

Filippo de Braud

Who can join

18 and older, any sex, with Malignant Neoplasm or Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

In preclinical studies, cyclic calorie-restricted diets reduce the risk of several cancers and improve the antitumor activity of standard treatments against already established malignancies.In particular, the fasting mimicking diet (FMD), a plant-based, calorie-restricted, low carbohydrate, low-protein diet to be repeated cyclically every 3-4 weeks, enhances the antitumor activity of cytotoxic chemotherapy, while contemporarily protecting healthy tissues and stimulating antitumor immunity. Most of these effects are likely mediated by the reduction of blood glycemia and growth factors, such as insulin and insulin-like growth factor 1 (IGF-1). When administered to healthy volunteers, cyclic FMD has been shown to be safe and capable of reducing risk factors for different chronic diseases. However, the effects of the FMD in cancer patient populations have not been evaluated so far. This study aims to assess the safety, feasibility and metabolic effects of the FMD in cancer patients treated with different standard antitumor therapies. Patients with any malignancy, with the exception of small cell neuroendocrine tumors, will be considered for enrollment in this study. The FMD will be administered up to a maximum of 8 consecutive cycles in combination with standard adjuvant treatments or therapies for advanced disease.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Metabolic Regulation of Macrophage Polarization in Cancer.
   Mehla K, Singh PK. · · 2019 · cited 470× · PMID 31813459 · DOI 10.1016/j.trecan.2019.10.007
2. Fasting-mimicking diet and hormone therapy induce breast cancer regression.
   Caffa I, Spagnolo V, Vernieri C, Valdemarin F, et al · · 2020 · cited 263× · PMID 32669709 · DOI 10.1038/s41586-020-2502-7
3. Fasting-Mimicking Diet Is Safe and Reshapes Metabolism and Antitumor Immunity in Patients with Cancer.
   Vernieri C, Fucà G, Ligorio F, Huber V, et al · · 2022 · cited 249× · PMID 34789537 · DOI 10.1158/2159-8290.cd-21-0030
4. Warburg effect in colorectal cancer: the emerging roles in tumor microenvironment and therapeutic implications.
   Zhong X, He X, Wang Y, Hu Z, et al · · 2022 · cited 223× · PMID 36319992 · DOI 10.1186/s13045-022-01358-5
5. Insulin-Like Growth Factor 1 (IGF-1) Signaling in Glucose Metabolism in Colorectal Cancer.
   Kasprzak A. · · 2021 · cited 169× · PMID 34208601 · DOI 10.3390/ijms22126434
6. Effects of dietary intervention on human diseases: molecular mechanisms and therapeutic potential.
   Xiao YL, Gong Y, Qi YJ, Shao ZM, et al · · 2024 · cited 120× · PMID 38462638 · DOI 10.1038/s41392-024-01771-x
7. Dietary regulation in health and disease.
   Wu Q, Gao ZJ, Yu X, Wang P. · · 2022 · cited 98× · PMID 35871218 · DOI 10.1038/s41392-022-01104-w
8. Effects of short-term fasting on cancer treatment.
   de Groot S, Pijl H, van der Hoeven JJM, Kroep JR. · · 2019 · cited 87× · PMID 31113478 · DOI 10.1186/s13046-019-1189-9