Prehabilitation Program During Chemotherapy for Breast Cancer
Multimodal Prehabilitation Program That Combines Physical Exercise, Psychological Intervention and Nutritional Support to Improve the Response to Neoadjuvant Chemoterhapy in Early Breast Cancer Patients
Recruiting
N/AInterventional Study
Breast Cancer Early Stage Breast Cancer (Stage 1-3)Prehabilitation
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Female
Study type
Interventional
Purpose
Treatment
Participants needed
214 (estimated)
Sponsor
Hospital Clinic of Barcelona · Other
Who this trial is looking for
This trial is looking for women with early-stage breast cancer who need chemotherapy before surgery. Participants will either follow a special program with exercise, nutrition, and mental support or receive standard care during their treatment.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with non-metastatic breast cancer.
I am 18 years or older.
I can give my signed consent to participate.
I need to start chemotherapy before surgery.
You may not be able to join if
I cannot do moderate-to-high intensity physical exercise.
I am pregnant or breastfeeding.
I have another active cancer.
I have metastatic breast cancer.
I do more than 150 minutes of exercise weekly.
I am male.
I have a history of cancer treatment with chemotherapy.
I have a severe psychiatric illness.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
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Answer a few quick questions to see if you may meet the eligibility requirements.
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 elig…
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.
Trial Locations
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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-…
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).
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