Multicomponent Prehabilitation in Older Adults With Breast Cancer (PREHAB-BC65)

April 13, 2026 updated by: Nicolás Martínez Velilla, Fundacion Miguel Servet

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is a prospective, randomized, controlled, single-blind clinical trial designed to evaluate the effectiveness of a multicomponent prehabilitation program in older adults with breast cancer, incorporating biological characterization to explore predictors of treatment response.

The trial will be conducted at the Navarre University Hospital (Pamplona, Spain). A total of 90 ambulatory patients aged 65 years or older with a confirmed diagnosis of breast cancer will be recruited and randomly assigned in a 1:1:1 ratio to usual care, a home-based multicomponent exercise program based on the Vivifrail methodology, or a supervised hospital-based intervention.

All participants will undergo baseline frailty screening followed by a comprehensive geriatric assessment to characterize functional, cognitive, nutritional, and clinical status. Assessments will be repeated at predefined time points throughout the perioperative period and during follow-up.

The intervention is structured into preoperative and postoperative phases and includes individualized multicomponent exercise, nutritional optimization, and targeted management of geriatric syndromes. The hospital-based intervention consists of supervised sessions over eight weeks, while the home-based intervention is adapted to baseline functional status.

Clinical, functional, and biological data will be collected longitudinally to evaluate the impact of the intervention and to identify predictors of clinical outcomes and treatment response.

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
    • Navarre
      • Pamplona, Navarre, Spain, 31008
        • Recruiting
        • Hospital Universitario de Navarra
        • Contact:
        • Contact:
        • Principal Investigator:
          • Nicolás Martínez Velilla, MD, PhD
        • Sub-Investigator:
          • Bernardo Abel Cedeño Veloz, MD, PhD
        • Sub-Investigator:
          • Susana de la Cruz Sánchez, MD
        • Sub-Investigator:
          • Sara Esteban Gordillo, MD
        • Sub-Investigator:
          • Natalia Moras Pérez, MD
        • Sub-Investigator:
          • Fabricio Zambom Ferraresi, PhD
        • Sub-Investigator:
          • Marta Lorente Escudero, MD
        • Sub-Investigator:
          • Lucía Lozano Vicario, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in physical function assessed by Short Physical Performance Battery (SPPB)
Time Frame: Baseline to 8 weeks (end of prehabilitation program)
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 8-week intervention.
Baseline to 8 weeks (end of prehabilitation program)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of postoperative complications
Time Frame: Within 30 days after surgery
Occurrence of postoperative complications within 30 days after surgery, classified according to the Clavien-Dindo classification.
Within 30 days after surgery
Length of hospital stay
Time Frame: From date of surgery until hospital discharge, with a maximum follow-up of 30 days postoperatively
Number of days from surgery to hospital discharge.
From date of surgery until hospital discharge, with a maximum follow-up of 30 days postoperatively
Functional decline after surgery
Time Frame: Baseline to 30 days 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.
Baseline to 30 days after surgery
Health-related quality of life
Time Frame: Baseline to 8 weeks and 30 days post-surgery
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).
Baseline to 8 weeks and 30 days post-surgery
Adherence to the intervention
Time Frame: During the 8-week intervention period
Percentage of prescribed exercise sessions completed by participants.
During the 8-week intervention period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacion Miguel Servet

Investigators

  • Study Director: Marta Lorente Escudero, MD, Navarre Health Service (SNS-O), Navarre University Hospital (HUN), Pamplona, Spain

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Welch SA,Ward RE,Beauchamp MK,Leveille SG,Travison T,Bean JF

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 4, 2024

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

August 1, 2027

Study Registration Dates

First Submitted

March 31, 2026

First Submitted That Met QC Criteria

April 13, 2026

First Posted (Actual)

April 15, 2026

Study Record Updates

Last Update Posted (Actual)

April 15, 2026

Last Update Submitted That Met QC Criteria

April 13, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUN-PREHAB-BC-65

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared due to data protection regulations and institutional policies. De-identified data may be available from the corresponding author upon reasonable request, subject to ethical approval and data sharing agreements.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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