Clinical Trial

Multimodal Prehabilitation Program That Combines Physical Exercise, Psychological Intervention and Nutritional Support to Improve the Response to Neoadjuvant Chemoterhapy in Early Breast Cancer Patients

Study acronym: DIANA
Recruiting
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Summary
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-08-04.
Trial Details
NCT Number NCT07107594
Lead Sponsor Hospital Clinic of Barcelona
Collaborators: Fundació La Marató de TV3
Conditions Breast Cancer Early Stage Breast Cancer (Stage 1-3), Prehabilitation
Enrollment 214 participants
Start Date 2025-01-14
Primary Completion 2028-01 (estimated)
Study Completion 2028-03 (estimated)
Updated on ClinicalTrials.gov 2026-01-15