Multicomponent prehabilitation for older adults with breast cancer
Official title: Multidimensional Oncogeriatric Prehabilitation in Older Adults With Breast Cancer: A Randomized Controlled Trial Integrating Frailty and Biomarker Assessment
Run by Fundacion Miguel Servet · NCT07531836 · Data updated 2026-11-12
This program will test whether a multicomponent prehabilitation intervention (home-based or supervised) helps people aged 65 and older with breast cancer improve physical function, recovery after surgery, and quality of life while exploring biological markers that predict who benefits.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 65 Years and up |
| Sex | All |
| Enrollment | 90 (estimated) |
| Sponsor | Fundacion Miguel Servet Academic / other |
| Locations | 1 site (Pamplona, Navarre) |
| Status | Recruiting |
| Started | December 4, 2024 |
| Main results expected | March 2027 |
| Study ends | June 2028 |
| Registry record updated | September 29, 2026 |
| Trial ID | NCT07531836 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are ambulatory adults aged 65 or older with a confirmed diagnosis of breast cancer who are scheduled for elective curative surgery, can walk (with or without aids), and can give informed consent.
✕Probably not a fit
Patients who need urgent or emergency surgery, have severe cognitive impairment or severe functional dependency (e.g., bedridden), have medical contraindications to exercise, or have a life expectancy under three months are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, randomized, single-blind trial at a single Spanish tertiary center enrolling 90 ambulatory patients aged 65+ with breast cancer scheduled for elective curative surgery. Participants are randomized 1:1:1 to usual care, a home-based Vivifrail multicomponent exercise program, or a supervised hospital-based prehabilitation intervention, all combined with nutritional optimization and comprehensive geriatric assessment. Baseline frailty screening and comprehensive geriatric assessment are performed, and clinical, functional, and biological measures are collected at predefined perioperative and follow-up time points. The trial aims both to measure functional and clinical outcomes and to identify biological markers associated with frailty and differential response to prehabilitation.
Why it matters
Potential benefit: If successful, the program could improve pre- and postoperative physical function, reduce complications, shorten recovery, and help tailor prehabilitation using biomarker information.
How similar studies have gone: Prehabilitation programs have shown promise in surgical populations and some cancer groups, but randomized evidence in older adults with breast cancer and the use of biomarkers to predict response remain limited.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Hospital Universitario de Navarra
Pamplona, Navarre, Spain Recruiting
Study contacts
- Study coordinator: Marta Lorente Escudero, MD
- Email: marta.lorente.escudero@navarra.es
- Phone: +34 648148503
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.