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Effectiveness of a Multicomponent Prehabilitation Program Combined With Biomarker Characterization in Older Adults With Breast Cancer

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: f
View:

• Age ≥65 years

• Diagnosis of 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

Locations
Other Locations
Spain
Hospital Universitario de Navarra
RECRUITING
Pamplona
Contact Information
Primary
Marta Lorente Escudero, MD
marta.lorente.escudero@navarra.es
+34 648148503
Backup
Nicolás Martínez Velilla, PhD
nicolas.martinez.velilla@navarra.es
+34 670900434
Time Frame
Start Date: 2024-12-04
Estimated Completion Date: 2027-08
Participants
Target number of participants: 90
Treatments
No_intervention: Usual Care
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.
Experimental: Home-based Multicomponent Prehabilitation (Vivifrail)
Participants perform a home-based multicomponent exercise program based on the Vivifrail methodology, including strength, endurance, balance, and flexibility training. The program is tailored according to baseline functional status and supported by caregiver supervision. Participants also receive comprehensive geriatric assessment and nutritional optimization.
Experimental: Supervised Multicomponent Prehabilitation
Participants receive a supervised multicomponent exercise program delivered in the hospital setting, including aerobic, resistance, balance, and flexibility training over eight weeks. The intervention is combined with comprehensive geriatric assessment, nutritional optimization, and individualized management of geriatric syndromes.
Related Therapeutic Areas
Sponsors
Leads: Fundacion Miguel Servet

This content was sourced from clinicaltrials.gov