Linking tumor immune infiltration to enhanced longevity in recurrence-free breast cancer.
L Angelats, L Paré, C Rubio-Perez...
https://pubmed.ncbi.nlm.nih.gov/39765189/Actively Recruiting
Led by Hospital Clinic of Barcelona · Updated on 2026-01-15
214
Participants Needed
1
Research Sites
8 weeks
Total Duration
Researchers are evaluating whether a multimodal prehabilitation program that includes physical exercise, nutritional support, and psychological intervention during neoadjuvant chemotherapy can improve the pathological response in women with non-metastatic breast cancer. This study focuses on early breast cancer patients who are candidates for chemotherapy before surgery and aims to compare the treatment response and recovery between those receiving the prehabilitation program and those under standard care. Participants will be randomly assigned to one of two groups an intervention group receiving the multimodal prehabilitation program during chemotherapy for 4 to 6 months, and a control group receiving standard clinical management without prehabilitation. The prehabilitation program involves structured physical exercise sessions twice a week, psychological therapies such as mindfulness or anxiety management, and nutritional counseling tailored to each patients needs. Throughout the study, participants will be assessed at baseline, after chemotherapy, and following surgery to evaluate physical, psychological, and nutritional status, as well as changes in the tumor microenvironment. The main outcome measured is the pathological response to chemotherapy using the Residual Cancer Burden index. Secondary outcomes include treatment tolerance, quality of life, postoperative recovery, and various health and tumor-related assessments over up to one year after surgery.
CONDITIONS
Multimodal Prehabilitation Program That Combines Physical Exercise, Psychological Intervention and Nutritional Support to Improve the Response to Neoadjuvant Chemoterhapy in Early Breast Cancer Patients
H
Helena Castillo Espín, MD
E
Eduard Mension Coll, MD, PhD
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Hospital Clinic of Barcelona
Lead Sponsor
Fundació La Marató de TV3
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 to 6 months
Participants undergo neoadjuvant chemotherapy (NACT) for 4 to 6 months. Those in the intervention group follow a multimodal prehabilitation program during this period, combining physical exercise, psychological therapy, and nutritional counseling. Participants in the control group receive standard clinical management with lifestyle advice but without structured interventions.
Physical exercise sessions twice a week; periodic psychological and nutritional counseling sessions; chemotherapy visits as per clinical schedule
Duration - 1 day
After completing NACT, participants undergo surgery to remove the tumor. The pathological response to treatment will be assessed during this stage.
1 visit (in-person) for surgery
Duration - Up to 30 days after surgery
Participants are monitored for recovery after surgery, including pain control and assessment of post-operative complications for up to 30 days after the operation.
Approximately 5 to 7 post-operative visits in hospital or clinic
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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https://pubmed.ncbi.nlm.nih.gov/24529560/Hospital Clinic of Barcelona
Lead Sponsor
Fundació La Marató de TV3
Collaborating Sponsor