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)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Eastern Piedmont

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)

Treatment groups

160 Participants
are divided into 4 treatment groups

Sponsors and collaborators