Clinical Trial

Impact of "Targeted" Nutritional Apport and Exercise on the Modulation of Metabolic and Immune-related Gene Expression Signatures in Early Breast Cancer (eBC) Patients Candidate to Neoadjuvant Therapy (NAT)

Study acronym: NEOMET
Recruiting
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Summary
NEOMET is an exploratory randomized prospective, multicenter study whose primary aim is to explore if metabolomic signatures can be modified by a lifestyle intervention including dietary supplements and physical exercise intervention, in eBC patients candidate to NAT. Eligible patients will be randomised to one of 4 groups: A. NAT, according to molecular subtype; B. NAT plus nutritional supplementation; C. NAT plus supervised physical exercise; D. NAT plus supervised physical exercise plus nutritional supplementation. Nutritional supplementazion will consist of two main long-chain polyunsaturated fatty acids omega-3 (n-3 Lc-PUFA), EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid) plus a source of palmitoleic acid (hexadecenoic acid).
Trial Details
NCT Number NCT06928701
Lead Sponsor University of Eastern Piedmont
Conditions Early Breast Cancer, Neoadjuvant Treatment
Enrollment 160 participants
Start Date 2024-09-01
Primary Completion 2026-09 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2025-04-15