NCT07107594 Multimodal Prehabilitation Program That Combines Physical Exercise, Psychological Intervention and Nutritional Support to Improve the Response to Neoadjuvant Chemoterhapy in Early Breast Cancer Patients
| NCT ID | NCT07107594 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospital Clinic of Barcelona |
| Condition | Breast Cancer Early Stage Breast Cancer (Stage 1-3) |
| Study Type | INTERVENTIONAL |
| Enrollment | 214 participants |
| Start Date | 2025-01-14 |
| Primary Completion | 2028-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 214 participants in total. It began in 2025-01-14 with a primary completion date of 2028-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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).
Contact & Investigator
Berta Díaz-Feijoo, MD, PhD
STUDY DIRECTOR
Hospital Clinic of Barcelona
Frequently Asked Questions
Who can join the NCT07107594 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Breast Cancer Early Stage Breast Cancer (Stage 1-3). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07107594 currently recruiting?
Yes, NCT07107594 is actively recruiting participants. Contact the research team at hcastillo@clinic.cat for enrollment information.
Where is the NCT07107594 trial being conducted?
This trial is being conducted at Barcelona, Spain.
Who is sponsoring the NCT07107594 clinical trial?
NCT07107594 is sponsored by Hospital Clinic of Barcelona. The principal investigator is Berta Díaz-Feijoo, MD, PhD at Hospital Clinic of Barcelona. The trial plans to enroll 214 participants.
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