About this trial
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).
Eligibility criteria
Qualifiers
- Women (regardless of menopausal status) ≥ 18 years of age
Pathologic confirmation of breast cancer by tumor biopsy
Immunohistochemical assessment (as per local standards) of ER and PgR status, HER2 status;
Stage I-III breast cancer without evidence of distant metastases
Disqualifiers
- locally advanced or inflammatory or stage IV BC;
tumor size < 1 cm with negative nodes (pT1a, N0);
chronic diseases or orthopedic issues that might interfere with ability to undertake a dietary and physical activity program;
personal history of eating disorders.
Trial design
Treatments tested in this trial
- omega-3 (n-3 Lc-PUFA), EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid) plus a source of palmitoleic acid (hexadecenoic acid)