The aim of this clinical trial is to evaluate whether following a multimodal prehabilitation program including physical exercise, nutritional support and psychological intervention during neoadjuvant chemotherapy in breast cancer patients could improve the pathological response to chemotherapy.
214 women with non-metastatic breast cancer with indication of chemotherapy before surgery will be eligible to participate. Patients will be randomly assigned to either the intervention group or the control group.
* Patients assigned to the intervention group (107 women) will undergo a directed multimodal prehabilitation program during the chemotherapy (4-6 months), including structured physical exercise, psychological intervention and nutritional guidance. * Patients assigned to the control group (107 women) will undergo standard clinical management for their disease without multimodal prehabilitation.
The response to chemotherapy between the two groups will be evaluated and compared. It is expected that multimodal prehabilitation will increase the response to chemotherapy and will improve the postoperative recovery of patients and their quality of life, as well as reducing the number of complications from surgery and chemotherapy treatment. Changes in the tumor microenvironment are also expected after prehabilitation.
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.
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).
Hospital Clinic of Barcelona
Lead sponsor
Fundació La Marató de TV3
Collaborator