Impact of diet and exercise on early breast cancer treatment
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)
This study is testing if adding diet and exercise to standard breast cancer treatment can help improve health and treatment outcomes for women with early-stage breast cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Eastern Piedmont Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Novara, Novara) |
| Trial ID | NCT06928701 on ClinicalTrials.gov |
What this trial studies
This exploratory randomized prospective study aims to investigate whether lifestyle interventions, including dietary supplements and physical exercise, can modify metabolomic signatures in early breast cancer patients who are candidates for neoadjuvant therapy. Participants will be randomized into four groups: standard neoadjuvant therapy, therapy plus nutritional supplementation, therapy plus supervised exercise, and therapy plus both exercise and supplementation. The study will assess various outcomes, including metabolic profiles, immune responses, and quality of life, over a total duration of 26 months. The primary focus is on understanding how these interventions can influence treatment responses and patient health.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older with pathologically confirmed early-stage breast cancer who are eligible for neoadjuvant therapy.
Not a fit: Patients with locally advanced, inflammatory, or stage IV breast cancer, or those with chronic diseases that hinder participation in dietary and exercise programs, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance treatment responses and improve health outcomes for early breast cancer patients.
How similar studies have performed: While similar lifestyle interventions have shown promise in other studies, this specific approach combining dietary supplementation and exercise in early breast cancer patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Novara, Novara
- AOU Maggiore della Carità — Novara, Novara, Italy (Recruiting)
Study contacts
- Study coordinator: Carmen Branni, BSc
- Email: carmen.branni@uniupo.it
- Phone: +3903213732292
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.