Phase II Study of Nutritional Supplements and Exercise Effects on Metabolic and Immune Gene Changes in Early Breast Cancer Patients Receiving Neoadjuvant Therapy

What this Trial Is About

Researchers are investigating how lifestyle changes, including dietary supplements and physical exercise, may affect metabolic and immune-related gene expression in women with early breast cancer eBC who are candidates for neoadjuvant therapy NAT. This exploratory randomized multicenter study aims to see if these interventions can change metabolomic signatures and improve responses to treatment. The study also evaluates the Omega-3 Index and its relation to therapy outcomes and patient metabolic profiles. Participants will be assigned randomly to one of four groups standard neoadjuvant therapy alone therapy plus nutritional supplements containing omega-3 fatty acids EPA and DHA and palmitoleic acid therapy plus supervised physical exercise or a combination of therapy, exercise, and supplements. Nutritional supplements include specific doses of omega-3 and palmitoleic acid given daily. The neoadjuvant therapy duration is about six months, tailored to each patients breast cancer subtype. During the study, participants will be monitored at baseline and before surgery, with assessments including fatty acid levels, Omega-3 Index, body composition, lymphocyte subpopulation immunophenotyping, gene expression in tumor tissue, and quality of life questionnaires. Safety and treatment-related side effects are also tracked before each therapy cycle. The total study duration includes data collection and analysis over approximately 26 months, involving around 160 patients evenly distributed across the four groups.

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)