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NCT03595540
Fasting-mimicking Diet in Patients Undergoing Active Cancer Treatment
NA trial testing Prolon in Cancer in 90 participants. Completed in 15 April 2021.
15 April 2021
Quick facts
| Lead sponsor | University of Genova |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | other |
| Enrollment | 90 |
| Start date | 22 November 2017 |
| Primary completion | 15 April 2021 |
| Estimated completion | 15 April 2021 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Prolon
Conditions studied
- Cancer — all drugs for Cancer →
- Breast Cancer — all drugs for Breast Cancer →
- Colorectal Cancer — all drugs for Colorectal Cancer →
Sponsor
University of Genova
Who can join
18 and older, any sex, with Cancer or Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a pilot, single arm prospective trial assessing feasibility, safety and effects on patient nutritional status of a 5-day fasting-mimicking diet (FMD) in patients with different cancer types and concomitant anticancer treatment.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Metabolic Regulation of Macrophage Polarization in Cancer.
Mehla K, Singh PK. · · 2019 · cited 470× · PMID 31813459 · DOI 10.1016/j.trecan.2019.10.007 -
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 -
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 -
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 -
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 -
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 -
Modulating gut microbiome in cancer immunotherapy: Harnessing microbes to enhance treatment efficacy.
Kang X, Lau HC, Yu J. · · 2024 · cited 65× · PMID 38631285 · DOI 10.1016/j.xcrm.2024.101478 -
Nutrients in the Prevention of Alzheimer's Disease.
Cremonini AL, Caffa I, Cea M, Nencioni A, et al · · 2019 · cited 65× · PMID 31565158 · DOI 10.1155/2019/9874159
Verify or expand the search:
- PubMed search for NCT03595540
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03595540 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Genova
- Last refreshed: 20 October 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03595540.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing