Clinical trial · Interventional
Multicomponent Prehabilitation in Older Adults With Breast Cancer
Multidimensional Oncogeriatric Prehabilitation in Older Adults With Breast Cancer: A Randomized Controlled Trial Integrating Frailty and Biomarker Assessment
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 30, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260930-000001
Summary
Brief summary (as posted)
Older adults with breast cancer frequently present with frailty, decreased functional reserve, and increased risk of postoperative complications. Prehabilitation programs have emerged as a promising strategy to improve physical function and clinical outcomes; however, evidence in geriatric oncology remains limited, particularly regarding the role of biological markers in predicting response to such interventions. This study aims to evaluate the effectiveness of a multicomponent prehabilitation program in older adults with breast cancer, focusing on functional status, clinical outcomes, and quality of life. In addition, the study seeks to characterize biological markers associated with frailty and treatment response, with the goal of identifying potential predictors of benefit from prehabilitation. Participants will undergo a structured prehabilitation intervention including physical exercise, nutritional optimization, and comprehensive geriatric assessment. Clinical, functional, and biomarker data will be collected longitudinally. The results of this study may contribute to improving personalized care strategies in geriatric oncology and to identifying patients who are most likely to benefit from prehabilitation programs.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Aging | — | UNRESOLVED | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Frailty | — | UNRESOLVED | — |
| Functional Decline | — | UNRESOLVED | — |
| Sarcopenia | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Comprehensive Geriatric Assessment and Optimization | Other | — | UNRESOLVED |
| Home-based Multicomponent Prehabilitation (Vivifrail) | Behavioral | — | UNRESOLVED |
| Supervised Multicomponent Prehabilitation | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- NO_INTERVENTION
- label
- Usual Care
- description
- Participants receive standard clinical care according to routine practice, including management by oncology and surgical teams. Identified geriatric conditions are communicated to the treating physician for appropriate management.
- type
- EXPERIMENTAL
- label
- Home-based Multicomponent Prehabilitation (Vivifrail)
- description
- Participants perform a home-based multicomponent exercise program based on the Vivifrail methodology, including strength, endurance, balance, and flexibility training over six weeks, comprising a 2-week preoperative phase and a 4-week postoperative phase. The program is tailored according to baseline functional status and supported by caregiver supervision. Participants also receive comprehensive geriatric assessment and nutritional optimization.
- interventionNames
- Behavioral: Home-based Multicomponent Prehabilitation (Vivifrail)
- Other: Comprehensive Geriatric Assessment and Optimization
- type
- EXPERIMENTAL
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥65 years * Diagnosis of breast cancer requiring elective surgery with curative intent * Candidate for prehabilitation program before surgery * Ability to walk (with or without assistive devices) * Ability to provide informed consent Exclusion Criteria: * Urgent or emergency surgery * Severe cognitive impairment precluding participation in the intervention * Severe functional dependency (e.g., bedridden patients) * Medical contraindication to physical exercise * Life expectancy \<3 months
References
Publications (1)
- RESULTWelch SA, Ward RE, Beauchamp MK, Leveille SG, Travison T, Bean JF. The Short Physical Performance Battery (SPPB): A Quick and Useful Tool for Fall Risk Stratification Among Older Primary Care Patients. J Am Med Dir Assoc. 2021 Aug;22(8):1646-1651. doi: 10.1016/j.jamda.2020.09.038. Epub 2020 Nov 13. PMID 33191134