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)
Recruiting · NCT06928701 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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).
Who can take part
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
Where it is running
1 location listed.
- AOU Maggiore della Carità - Novara, Novara, Italy