Clinical trial · Interventional
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)
A Phase II Randomized Trial to Evaluate the 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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Early Breast Cancer | Breast Neoplasm | PROBABILISTIC | 0.70 |
| Neoadjuvant Treatment | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| omega-3 (n-3 Lc-PUFA), EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid) plus a source of palmitoleic acid (hexadecenoic acid) | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- NO_INTERVENTION
- label
- A - treatment of physician choice
- description
- 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).
- type
- EXPERIMENTAL
- label
- B - nutritional supplementation
- description
- 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.
- interventionNames
- Dietary Supplement: omega-3 (n-3 Lc-PUFA), EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid) plus a source of palmitoleic acid (hexadecenoic acid)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available