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)

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).

Eligibility

Inclusion Criteria:

* \- 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
* Being candidate to standard neoadjuvant therapy
* Having available tumor tissue from breast and/or lymph node at baseline
* Ability to fill a nutritional daily diary
* Medical clearance for non-agonistic physical activity
* Written informed consent to study-specific procedures

Exclusion Criteria:

* \- 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.
* women engaged in agonistic/vigorous sport activities, not able to be compliant to exercise schedules

Conditions4

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