Status:
RECRUITING
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)
Lead Sponsor:
University of Eastern Piedmont
Conditions:
Early Breast Cancer
Neoadjuvant Treatment
Eligibility:
FEMALE
18+ years
Phase:
NA
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 a...
Detailed Description
The primary objectives are: 1. To explore the impact of a lifestyle intervention including dietary supplements and physical exercise on the modulation of metabolomic signatures in eBC patients candida...
Eligibility Criteria
Inclusion
- \- 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
- \- 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
Key Trial Info
Start Date :
September 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT06928701
Start Date
September 1 2024
End Date
December 1 2026
Last Update
April 15 2025
Active Locations (1)
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1
AOU Maggiore della Carità
Novara, Novara, Italy, 28100