NCT06928701 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)
| NCT ID | NCT06928701 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Eastern Piedmont |
| Condition | Early Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2024-09-01 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 160 participants in total. It began in 2024-09-01 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Alessandra Gennari, MD
STUDY CHAIR
University of Piemonte Orientale
Frequently Asked Questions
Who can join the NCT06928701 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Early Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06928701 currently recruiting?
Yes, NCT06928701 is actively recruiting participants. Contact the research team at carmen.branni@uniupo.it for enrollment information.
Where is the NCT06928701 trial being conducted?
This trial is being conducted at Novara, Italy.
Who is sponsoring the NCT06928701 clinical trial?
NCT06928701 is sponsored by University of Eastern Piedmont. The principal investigator is Alessandra Gennari, MD at University of Piemonte Orientale. The trial plans to enroll 160 participants.
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