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)
omega-3 (n-3 Lc-PUFA), EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid) plus a source of palmitoleic acid (hexadecenoic acid)
omega-3 (n-3 Lc-PUFA), EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid) plus a source of palmitoleic acid (hexadecenoic acid): Nutritional supplements
Study 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
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Variation of fatty acids concentration — T0: baseline, prior to cycle 1 (each cycle is 21 days); T1: end of NACT, before surgery (NACT is approximately 6 months, according to biological subtype) 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 — T0: baseline, prior to cycle 1 (each cycle is 21 days); T1: end of NACT, before surgery (NACT is approximately 6 months, according to biological subtype) 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.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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