Impact of diet and exercise on early breast cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• AOU Maggiore della Carità
  Novara, Novara, Italy Recruiting

Study contacts

• Study coordinator: Carmen Branni, BSc
• Email: carmen.branni@uniupo.it
• Phone: +3903213732292

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.