Clinical trial · Interventional
Multimodal Prehabilitation Program That Combines Physical Exercise, Psychological Intervention and Nutritional Support to Improve the Response to Neoadjuvant Chemoterhapy in Early Breast Cancer Patients
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Early Stage Breast Cancer (Stage 1-3) | Breast Neoplasm | PROBABILISTIC | 0.70 |
| Prehabilitation | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Multimodal prehabilitation | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Control
- description
- 107 women that will follow the standard of care. Patients in the control group will receive proper information and recommendations about lifestyle modifications according to the most recent oncological guidelines. The benefits of physical exercise, a healthy diet and psychological support will be exposed, but such interventions will not be provided in our centre.
- type
- EXPERIMENTAL
- label
- Prehabilitation
- description
- 107 women that will follow the multimodal prehabilitation program during NACT (physical exercise, psychological intervention, nutritional support).
- interventionNames
- Behavioral: Multimodal prehabilitation
Primary outcomes (1)
- measure
- Residual Cancer Burden Index (RCB)
- timeFrame
- From enrollment (baseline, day 1) until the end of treatment at 4-6 months (preoperative).
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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).
References
Publications (17)
- BACKGROUNDAngelats L, Pare L, Rubio-Perez C, Sanfeliu E, Gonzalez A, Segui E, Villacampa G, Marin-Aguilera M, Pernas S, Conte B, Albarran-Fernandez V, Martinez-Saez O, Aguirre A, Galvan P, Fernandez-Martinez A, Cobo S, Rey M, Martinez-Romero A, Walbaum B, Schettini F, Vidal M, Buckingham W, Munoz M, Adamo B, Agrawal Y, Guedan S, Pascual T, Agudo J, Grzelak M, Borcherding N, Heyn H, Vivancos A, Parker JS, Villagrasa P, Perou CM, Prat A, Braso-Maristany F. Linking tumor immune infiltration to enhanced longevity in recurrence-free breast cancer. ESMO Open. 2025 Jan;10(1):104109. doi: 10.1016/j.esmoop.2024.104109. Epub 2025 Jan 6. PMID 39765189
- BACKGROUNDToohey K, Hunter M, McKinnon K, Casey T, Turner M, Taylor S, Paterson C. A systematic review of multimodal prehabilitation in breast cancer. Breast Cancer Res Treat. 2023 Jan;197(1):1-37. doi: 10.1007/s10549-022-06759-1. Epub 2022 Oct 21. PMID 36269525
- BACKGROUNDDenkert C, von Minckwitz G, Darb-Esfahani S, Lederer B, Heppner BI, Weber KE, Budczies J, Huober J, Klauschen F, Furlanetto J, Schmitt WD, Blohmer JU, Karn T, Pfitzner BM, Kummel S, Engels K, Schneeweiss A, Hartmann A, Noske A, Fasching PA, Jackisch C, van Mackelenbergh M, Sinn P, Schem C, Hanusch C, Untch M, Loibl S. Tumour-infiltrating lymphocytes and prognosis in different subtypes of breast cancer: a pooled analysis of 3771 patients treated with neoadjuvant therapy. Lancet Oncol. 2018 Jan;19(1):40-50. doi: 10.1016/S1470-2045(17)30904-X. Epub 2017 Dec 7. PMID 29233559
- BACKGROUNDValenza C, Taurelli Salimbeni B, Santoro C, Trapani D, Antonarelli G, Curigliano G. Tumor Infiltrating Lymphocytes across Breast Cancer Subtypes: Current Issues for Biomarker Assessment. Cancers (Basel). 2023 Jan 26;15(3):767. doi: 10.3390/cancers15030767. PMID 36765724
- BACKGROUNDWiggins JM, Opoku-Acheampong AB, Baumfalk DR, Siemann DW, Behnke BJ. Exercise and the Tumor Microenvironment: Potential Therapeutic Implications. Exerc Sport Sci Rev. 2018 Jan;46(1):56-64. doi: 10.1249/JES.0000000000000137. PMID 29166299