Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
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)

Led by University of Eastern Piedmont · Updated on 2025-04-15

160

Participants Needed

1

Research Sites

117 weeks

Total Duration

On this page

AI-Summary

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).

CONDITIONS

Official Title

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)

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • - 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
Not Eligible

You will not qualify if you...

  • - 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

AI-Screening

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Trial Site Locations

Total: 1 location

1

AOU Maggiore della Carità

Novara, Novara, Italy, 28100

Actively Recruiting

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Research Team

C

Carmen Branni, BSc

CONTACT

I

Ida Taglialatela, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

4

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