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RECRUITING Not applicable ClinicalTrials.gov

Multicomponent Prehabilitation in Older Adults With Breast Cancer

Sponsor: Fundacion Miguel Servet • ClinicalTrials.gov ID: NCT07531836

Registry updated: 2026-09-29
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Description

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.

Interventions

  • Home-based Multicomponent Prehabilitation (Vivifrail) (Behavioral)
    Participants perform a structured home-based multicomponent exercise program based on the Vivifrail methodology, including strength, endurance, balance, and flexibility training over six weeks. The program is individualized according to baseline functional status.
  • Supervised Multicomponent Prehabilitation (Behavioral)
    Participants receive a structured, supervised multicomponent exercise program delivered in a hospital setting, including aerobic, strength, balance, and flexibility training over six weeks.
  • Comprehensive Geriatric Assessment and Optimization (Other)
    Participants undergo comprehensive geriatric assessment with targeted interventions including nutritional optimization, medication review, and management of geriatric syndromes.

Eligibility criteria

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

Conditions

Breast Cancer Frailty Sarcopenia Aging Functional Decline

Locations

  • Hospital Universitario de Navarra — Pamplona, Navarre, Spain
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record