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/39765189Actively Recruiting
Phase Not Applicable
Age: 18Years +
FEMALE
ID07107594
Multimodal Intervention During Neoadjuvant Chemotherapy in Patients With Early-breast Cancer as a Strategy to Improve Treatment Response: DIANA Trial (Multimodal Prehabilitation: DIet, ANxiety Control Psychotherapy, Physical Activity)
Led by Hospital Clinic of Barcelona · Updated on 2026-01-15
214
Participants Needed
1
Research Sites
8 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
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 patient's 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
Brief 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
Age: 18Years +
FEMALE
Eligibility Criteria
You may qualify if you...
- Histologically confirmed diagnosis of non-metastatic breast cancer: stages cT1-T4, cN0-N3, M0, and candidates for neoadjuvant chemotherapy (NAC).
- Age 18 years or older.
- Signed informed consent.
You will not qualify if you...
- 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).
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
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
Surgery
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
Post-operative Follow-up
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
Trial Site Locations
Total: 1 location
1
Hospital Clínic de Barcelona
Barcelona, Spain
Actively Recruiting
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Research Team
H
Helena Castillo Espín, MD
E
Eduard Mension Coll, MD, PhD
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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Published Research Related To This Trial
A systematic review of multimodal prehabilitation in breast cancer.
Kellie Toohey, Maddison Hunter, Karen McKinnon...
https://pubmed.ncbi.nlm.nih.gov/36269525Tumour-infiltrating lymphocytes and prognosis in different subtypes of breast cancer: a pooled analysis of 3771 patients treated with neoadjuvant therapy.
Carsten Denkert, Gunter von Minckwitz, Silvia Darb-Esfahani...
https://pubmed.ncbi.nlm.nih.gov/29233559Tumor Infiltrating Lymphocytes across Breast Cancer Subtypes: Current Issues for Biomarker Assessment.
Carmine Valenza, Beatrice Taurelli Salimbeni, Celeste Santoro...
https://pubmed.ncbi.nlm.nih.gov/36765724Exercise and the Tumor Microenvironment: Potential Therapeutic Implications.
Jennifer M Wiggins, Alexander B Opoku-Acheampong, Dryden R Baumfalk...
https://pubmed.ncbi.nlm.nih.gov/29166299Effect of Low-Intensity Physical Activity and Moderate- to High-Intensity Physical Exercise During Adjuvant Chemotherapy on Physical Fitness, Fatigue, and Chemotherapy Completion Rates: Results of the PACES Randomized Clinical Trial.
Hanna van Waart, Martijn M Stuiver, Wim H van Harten...
https://pubmed.ncbi.nlm.nih.gov/25918291Physical Activity Before, During, and After Chemotherapy for High-Risk Breast Cancer: Relationships With Survival.
Rikki A Cannioto, Alan Hutson, Shruti Dighe...
https://pubmed.ncbi.nlm.nih.gov/32239145Physical Activity and Breast Cancer: an Opportunity to Improve Outcomes.
Lindsay L Peterson, Jennifer A Ligibel
https://pubmed.ncbi.nlm.nih.gov/29713835Stressful Life Events and Distress in Breast Cancer: A 5-Years Follow-Up.
Cristian Ochoa-Arnedo, Clàudia Prats, Noemie Travier...
https://pubmed.ncbi.nlm.nih.gov/35572072Meta-analysis of psychosocial interventions on survival time in patients with cancer.
P J Oh, S R Shin, H S Ahn...
https://pubmed.ncbi.nlm.nih.gov/26518363