Multimodal prehabilitation combining exercise, nutrition, and psychological support to improve chemotherapy response in early breast cancer

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 randomized trial will enroll 214 women with non-metastatic (stage I–III) breast cancer who are scheduled for neoadjuvant chemotherapy and assign them 1:1 to either a multimodal prehabilitation program or standard care. The intervention group will receive structured physical exercise, nutritional guidance, and psychological support during the 4–6 months of chemotherapy, while the control group will receive routine clinical management. The primary comparison is the pathological response to chemotherapy at the time of surgery, with secondary outcomes likely including quality of life and treatment tolerance. The program seeks to optimize patients' physical and emotional condition and may favorably affect tumor microenvironment factors that influence treatment response.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Histologically confirmed diagnosis of non-metastatic breast cancer: stages cT1-T4, cN0-N3, M0, and candidates for neoadjuvant chemotherapy (NAC).
* Age ≥ 18 years.
* Signed informed consent.

Exclusion Criteria:

* Contraindication or physical inability to perform moderate-to-high intensity physical exercise.
* Pregnant or breastfeeding patients.
* Presence of other active synchronous neoplasms.
* Metastatic breast cancer (stage IV).
* Patients already engaging in regular physical exercise: more than 150 minutes of moderate or intense aerobic exercise per week.
* Male breast cancer patients.
* Personal history of a previous malignancy treated with chemotherapy.
* Severe or poorly controlled psychiatric illness (including uncontrolled active substance abuse).

Where it's running

• Hospital Clínic de Barcelona
  Barcelona, Spain Recruiting

Study contacts

• Study coordinator: Helena Castillo Espín, MD
• Email: hcastillo@clinic.cat
• Phone: +34 651024667

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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.