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).
- 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
- 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.
Parallel
omega-3 (n-3 Lc-PUFA), EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid) plus a source of palmitoleic acid (hexadecenoic acid)
Dietary supplementNutritional supplements
Variation of fatty acids concentration
Plasma metabolic sample will be analyzed using a GCxGC-MS instrument for the relative and absolute quantification of small molecules in order to evaluate the impact of a lifestyle intervention including dietary supplements and physical exercise on the modulation of metabolomic signatures in eBC patients candidate to NACT.
Omega3 Index
Assessment of Omega-3 Index in all patients cohorts at: * baseline * pre-operatative (at the end of NACT) The omega3 index will assessed by the sum of DHA and EPA in erythrocytes expressed as a percentage of total erythrocyte fatty acid.
Combined lifestyle intervention
Impact of the combined lifestyle intervention on body composition. Body composition will be assessed with a multifrequency bioelectrical impedance analysis.
Lymphocyte subpopulations
Assessment of the immunophenotype of lymphocyte subpopulations and their correlation with metabolomic profile and response to therapy; characterization of immune-related and metabolic-related gene-expression signatures in tumor tissue and their correlation with metabolomic profile and response to therapy. Lymphocyte subpopulation will be assessed collecting blood at 1st cycle and at the last cycle of NACT (before surgery). Gene-expression signatures will be assessed on tumor biopsy and surgery tissue.
Antitumor activity
evaluation of pathological Complete Response (pCR) in the different treatment arms (ypT0/Tis ypN0)
changes in health-related Quality of Life
Quality of Life will be assessed among all patients included in the study using patient-reported outcomes (PROs) collected using a validated and standardized questionnaire: the European Organization for Cancer Research and Treatment Quality of Life Questionnaire C30, ranging from 0 to 100. A high-scale score represents a higher response level.
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