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)

NCT06928701 | Recruiting

• 1 other identifier: 02UPODIMETONCO
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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).

Conditions

Early Breast Cancer; Neoadjuvant Treatment

Keywords

treatment response; metabolomics; nutritional intervention

Outcome Measures

Primary Outcomes (2)

• Variation of fatty acids concentration

  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.

  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)

• Omega3 Index

  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.

  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)

Secondary Outcomes (7)

• Combined lifestyle intervention

  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)

• Lymphocyte subpopulations

  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)

• Antitumor activity

  From T0 until surgery, approximately 6 months (according to biological subtype)

• changes in health-related Quality of Life

  T0: baseline, prior to cycle 1 (each cycle is 21 days); T1: at three months after inclusion; T2: end of NACT, before surgery (NACT is approximately 6 months, according to biological subtype)

• changes in health-related Quality of Life

  T0: baseline, prior to cycle 1 (each cycle is 21 days); T1: at three months after inclusion; T2: end of NACT, before surgery (NACT is approximately 6 months, according to biological subtype)

Study Arms (4)

A - treatment of physician choice

NO INTERVENTION

Conventional anti-cancer treatment, according to the molecular subtype and standard of care; all patients in Arm A will also receive general recommendations on lifestyle, including weight control and physical activity as indicated by WHO and EUSOMA criteria (control arm).

B - nutritional supplementation

EXPERIMENTAL

Conventional anti-cancer treatment, according to the molecular subtype plus nutritional supplementation. Patients will be required to take on a daily basis two main long-chain polyunsaturated fatty acids omega-3 (n-3 Lc-PUFA), EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid), respectively at a dose of 700mg and 240mg, through 1 softgel twice a day. Besides, patients will be provided with a source of palmitoleic acid (hexadecenoic acid) equivalent to 1000mg of pure palmitoleic acid on a daily basis, through one daily 7 ml vial.

Dietary Supplement: omega-3 (n-3 Lc-PUFA), EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid) plus a source of palmitoleic acid (hexadecenoic acid)

C - physical activity

EXPERIMENTAL

Conventional anti-cancer treatment, according to the molecular subtype plus indication for supervised physical exercise

Dietary Supplement: omega-3 (n-3 Lc-PUFA), EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid) plus a source of palmitoleic acid (hexadecenoic acid)

D - nutritional supplementation plus physical activity

EXPERIMENTAL

Conventional anti-cancer treatment, according to the molecular subtype plus indication for supervised exercise training plus nutritional supplementation

Dietary Supplement: omega-3 (n-3 Lc-PUFA), EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid) plus a source of palmitoleic acid (hexadecenoic acid)

Interventions

omega-3 (n-3 Lc-PUFA), EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid) plus a source of palmitoleic acid (hexadecenoic acid) DIETARY_SUPPLEMENT

Nutritional supplements

B - nutritional supplementation; C - physical activity; D - nutritional supplementation plus physical activity

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• University of Eastern Piedmont: lead

Study Sites (1)

AOU Maggiore della Carità

Novara, Novara, 28100, Italy

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Docosahexaenoic Acids; Eicosapentaenoic Acid; hexadecenoic acid

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils; Eicosanoids

Study Officials

• Alessandra Gennari, MD

  University of Piemonte Orientale

  STUDY CHAIR

Central Study Contacts

Carmen Branni, BSc

CONTACT

+3903213732292; carmen.branni@uniupo.it

Ida Taglialatela, MD

CONTACT

+3903213732292; ida.taglialatela@maggioreosp.novara.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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).

Study Record Dates

• First Submitted: July 3, 2024
• First Posted: April 15, 2025
• Study Start: September 1, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 15, 2025

Record last verified: 2025-04

Locations

IT (1)