Multicomponent Prehabilitation in Older Adults With Breast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorFundacion Miguel Servet
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Urgent or emergency surgery
Severe cognitive impairment precluding participation in the intervention
Severe functional dependency (e.g., bedridden patients)
Medical contraindication to physical exercise
Trial design
Design model
Parallel
Treatments tested in this trial
Home-based Multicomponent Prehabilitation (Vivifrail)
BehavioralParticipants 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
BehavioralParticipants 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 interventionParticipants undergo comprehensive geriatric assessment with targeted interventions including nutritional optimization, medication review, and management of geriatric syndromes.
Treatment groups
90 Participants
are divided into 3 treatment groupsGroup A: Usual CareNo intervention 0 interventions
Group B: Home-based Multicomponent Prehabilitation (Vivifrail)Experimental treatment 2 interventions
Group C: Supervised Multicomponent PrehabilitationExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Change in physical function assessed by Short Physical Performance Battery (SPPB)
Physical function will be assessed using the Short Physical Performance Battery (SPPB), a validated tool in older adults (score range 0-12, higher scores indicate better performance). The primary outcome will be the change in SPPB score from baseline to the end of the 6-week intervention period.
Time frame
Baseline to the end of the 6-week intervention periodSecondary outcomes
1
Incidence of postoperative complications
Occurrence of postoperative complications within 30 days after surgery, classified according to the Clavien-Dindo classification.
Time frame
Within 30 days after surgery2
Length of hospital stay
Number of days from surgery to hospital discharge.
Time frame
From date of surgery until hospital discharge, with a maximum follow-up of 30 days postoperatively3
Functional decline after surgery
Functional decline defined as a decrease in the Short Physical Performance Battery (SPPB) score (range 0 to 12, with higher scores indicating better physical performance) or loss of independence in activities of daily living compared to baseline.
Time frame
Baseline to 30 days after surgery4
Health-related quality of life
Health-related quality of life assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30; scores transformed to a 0-100 scale, where higher scores indicate better functioning or worse symptoms depending on the domain).
Time frame
Baseline to 30 days after surgerySponsors and contacts
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Source ClinicalTrials.gov