Actively Recruiting
Multimodal Prehabilitation Program That Combines Physical Exercise, Psychological Intervention and Nutritional Support to Improve the Response to Neoadjuvant Chemoterhapy in Early Breast Cancer Patients
Led by Hospital Clinic of Barcelona · Updated on 2026-01-15
214
Participants Needed
1
Research Sites
163 weeks
Total Duration
On this page
Sponsors
H
Hospital Clinic of Barcelona
Lead Sponsor
F
Fundació La Marató de TV3
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Multimodal Prehabilitation Program That Combines Physical Exercise, Psychological Intervention and Nutritional Support to Improve the Response to Neoadjuvant Chemoterhapy in Early Breast Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed diagnosis of non-metastatic breast cancer (stages cT1-T4, cN0-N3, M0) and candidate for neoadjuvant chemotherapy
- Age 18 years or older
- Signed informed consent
You will not qualify if you...
- Unable or contraindicated to perform moderate-to-high intensity physical exercise
- Pregnant or breastfeeding
- Presence of other active synchronous cancers
- Metastatic breast cancer (stage IV)
- Already performing more than 150 minutes of moderate or intense aerobic exercise per week
- Male breast cancer patients
- Previous cancer treated with chemotherapy
- Severe or poorly controlled psychiatric illness, including uncontrolled active substance abuse
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Trial Site Locations
Total: 1 location
1
Hospital Clínic de Barcelona
Barcelona, Spain
Actively Recruiting
Research Team
H
Helena Castillo Espín, MD
CONTACT
E
Eduard Mension Coll, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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