Clinical trial · Interventional
Impact of Prehabilitation and Comprehensive Follow-up in Women With Breast Cancer
Impact of Prehabilitation With Exercise and Nutrition, and Comprehensive Follow-up in Women With Breast Cancer: The PREACT Trial
- 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)
Breast cancer (BC) is the most common cancer among women worldwide. Cancer treatments are associated with numerous adverse events that reduce patients' functionality and alter their clinical and molecular profiles. Physical exercise and adherence to nutritional guidelines during treatment and survivorship have been shown to improve recovery prognosis and reduce treatment-related complications. However, the specific effects of prehabilitation, defined as "the process in the cancer continuum that occurs between diagnosis and the start of treatment," remain unknown in BC. A concurrent training program and specific nutritional guidelines during this phase could reduce treatment-related adverse events and improve recovery. Similarly, including a home-based exercise program and nutritional guidelines throughout the cancer treatment continuum could enhance the benefits achieved and improve various aspects of functionality, clinical status, and quality of life. Therefore, the main aim of this randomized controlled trial is to evaluate the impact and effects of a supervised prehabilitation program (combining high-intensity concurrent training and personalized nutritional guidelines) and a supportive care intervention (home-based exercise and personalized nutritional guidelines) on functional, neuromuscular, and cardiorespiratory capacity, quality of life, body composition, and clinical and molecular outcomes in women with BC. In addition, the sustainability of the benefits achieved in the long-term care and the evolution of the outcomes assessed throughout the continuum of cancer treatments will be analyzed.
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 | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Prehabilitation: Exercise and nutrition | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Exercise and nutrition group
- description
- Participants assigned to the experimental group will undergo a supervised prehabilitation program consisting of structured exercise training and personalized nutritional guidelines, followed by a home-based program (exercise and nutrition) during the treatment period.
- interventionNames
- Other: Prehabilitation: Exercise and nutrition
- type
- NO_INTERVENTION
- label
- Control group
- description
- Participants assigned to this group will be asked to continue their usual care and will receive general recommendations for physical activity and nutrition.
Primary outcomes (3)
- measure
- Cardiorespiratory fitness (peak oxygen consumption): Direct method
- timeFrame
- Baseline; up to 1 week before initiation of systemic therapy; up to 1 week after completion of systemic therapy; up to 1 week before initiation of radiotherapy; and up to 1 week after completion of radiotherapy.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Women who have a newly confirmed diagnosis of stage 0-III breast cancer. * Age 18 to 65 years old with a body mass index between 18.5 and 35 kg·m-². * Have a medical indication for surgery or neoadjuvant systemic treatment (chemotherapy or hormone therapy) or radiotherapy. * Be able to perform supervised physical exercise, as determined by prior medical assessment. * Understand and voluntarily sign the written informed consent before the start of the study. Exclusion Criteria: * Women with a diagnosis of metastatic breast cancer. * Women with any medical condition that contraindicates physical exercise, such as severe cardiovascular disease, significant respiratory or kidney failure. * Women with presence of serious uncontrolled comorbidities, such as decompensated diabetes, severe hypertension or acute psychiatric disorders, among others. * Women with severe functional limitations that prevent planned interventions from being performed (e.g., physical disabilities that compromise exercise). * Women who are pregnant, breastfeeding, or likely to become pregnant during the trial or who have inability to communicate.
References
Publications (12)
- BACKGROUNDFoulkes SJ, Howden EJ, Haykowsky MJ, Antill Y, Salim A, Nightingale SS, Loi S, Claus P, Janssens K, Mitchell AM, Wright L, Costello BT, Lindqvist A, Burnham L, Wallace I, Daly RM, Fraser SF, La Gerche A. Exercise for the Prevention of Anthracycline-Induced Functional Disability and Cardiac Dysfunction: The BREXIT Study. Circulation. 2023 Feb 14;147(7):532-545. doi: 10.1161/CIRCULATIONAHA.122.062814. Epub 2022 Nov 7. PMID 36342348
- BACKGROUNDForsythe LP, Alfano CM, George SM, McTiernan A, Baumgartner KB, Bernstein L, Ballard-Barbash R. Pain in long-term breast cancer survivors: the role of body mass index, physical activity, and sedentary behavior. Breast Cancer Res Treat. 2013 Jan;137(2):617-30. doi: 10.1007/s10549-012-2335-7. Epub 2012 Dec 15. PMID 23242613
- BACKGROUNDJiang M, Ma Y, Yun B, Wang Q, Huang C, Han L. Exercise for fatigue in breast cancer patients: An umbrella review of systematic reviews. Int J Nurs Sci. 2020 Mar 10;7(2):248-254. doi: 10.1016/j.ijnss.2020.03.001. eCollection 2020 Apr 10. PMID 32685623
- BACKGROUNDBull FC, Al-Ansari SS, Biddle S, Borodulin K, Buman MP, Cardon G, Carty C, Chaput JP, Chastin S, Chou R, Dempsey PC, DiPietro L, Ekelund U, Firth J, Friedenreich CM, Garcia L, Gichu M, Jago R, Katzmarzyk PT, Lambert E, Leitzmann M, Milton K, Ortega FB, Ranasinghe C, Stamatakis E, Tiedemann A, Troiano RP, van der Ploeg HP, Wari V, Willumsen JF. World Health Organization 2020 guidelines on physical activity and sedentary behaviour. Br J Sports Med. 2020 Dec;54(24):1451-1462. doi: 10.1136/bjsports-2020-102955. PMID 33239350
- BACKGROUNDTorcasio R, Gallo Cantafio ME, Ikeda RK, Ganino L, Viglietto G, Amodio N. Lipid metabolic vulnerabilities of multiple myeloma. Clin Exp Med. 2023 Nov;23(7):3373-3390. doi: 10.1007/s10238-023-01174-2. Epub 2023 Aug 28. PMID 37639069
- BACKGROUNDDemark-Wahnefried W, Campbell KL, Hayes SC. Weight management and its role in breast cancer rehabilitation. Cancer. 2012 Apr 15;118(8 Suppl):2277-87. doi: 10.1002/cncr.27466.