RecruitingNot ApplicableNCT06928701

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)

Sponsor

University of Eastern Piedmont

Enrollment

160 participants

Start Date

Sep 1, 2024

Study Type

INTERVENTIONAL

Conditions

Early Breast Cancer Neoadjuvant Treatment

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study looks at how a personalized nutrition and exercise program affects gene activity in women with early-stage breast cancer who are scheduled to receive chemotherapy before surgery (called neoadjuvant therapy). The goal is to understand if these lifestyle changes can improve outcomes. **You may be eligible if...** - You are a woman aged 18 or older (any menopausal status) - You have been diagnosed with Stage I–III breast cancer (no distant spread) - You are about to receive standard pre-surgery chemotherapy - You are able to keep a daily food diary - You are medically cleared for light physical activity **You may NOT be eligible if...** - You have locally advanced, inflammatory, or Stage IV breast cancer - You have a very small tumor with no lymph node involvement - You have a chronic illness or joint/orthopedic problem that prevents exercise - You have a history of eating disorders - You are currently engaged in intense competitive sports Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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

Nutritional supplements