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

RecruitingNAAges 18 Years - anyFemaleHospital Clinic of Barcelona
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In plain words

What the trial is, and whether it could suit you

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 prehabil

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Histologically confirmed diagnosis of non-metastatic breast cancer: stages cT1-T4, cN0-N3, M0, and candidates for neoadjuvant chemotherapy (NAC). * Age โ‰ฅ 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).
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What it tests

  • Multimodal prehabilitation
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Where

1 site
Hospital Clรญnic de Barcelona
Barcelona, Spain
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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