RecruitingNot ApplicableNCT06928701

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)

A Phase II Randomized Trial to Evaluate the 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)

Sponsor

University of Eastern Piedmont

Enrollment

160 participants

Start Date

Sep 1, 2024

Study Type

INTERVENTIONAL

Conditions

Early Breast Cancer Neoadjuvant Treatment

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

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria9

\- 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 Criteria5

\- 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

Interventions

DIETARY_SUPPLEMENTomega-3 (n-3 Lc-PUFA), EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid) plus a source of palmitoleic acid (hexadecenoic acid)

Nutritional supplements