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NCT Number: NCT07531836

Multicomponent Prehabilitation 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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario de Navarra

Pamplona, Navarre, 31008, Spain

Location status: Recruiting

Location contact

Bernardo Abel Cedeño Veloz, MD, PhD

SUB_INVESTIGATOR

Fabricio Zambom Ferraresi, PhD

SUB_INVESTIGATOR

Lucía Lozano Vicario, MD, PhD

SUB_INVESTIGATOR

Marta Lorente Escudero, MD

CONTACT

[email protected]

+34 648148503

Marta Lorente Escudero, MD

SUB_INVESTIGATOR

Natalia Moras Pérez, MD

SUB_INVESTIGATOR

Nicolás Martínez Velilla, MD, PhD

CONTACT

[email protected]

+34 670900434

Nicolás Martínez Velilla, MD, PhD

PRINCIPAL_INVESTIGATOR

Sara Esteban Gordillo, MD

SUB_INVESTIGATOR

Susana de la Cruz Sánchez, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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. 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 eight 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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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).

  5. Adherence to the intervention

    Time frame: During the 8-week intervention period

    Percentage of prescribed exercise sessions completed by participants.

Study contacts

Contact information is provided by the study sponsor or research team.

Marta Lorente Escudero, MD

CONTACT

[email protected]

+34 648148503

Nicolás Martínez Velilla, PhD

CONTACT

[email protected]

+34 670900434

Sponsors and collaborators

Lead sponsor

Fundacion Miguel Servet

Other

Registry information

Official study title

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

Acronym: PREHAB-BC65

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Apr 15, 2026
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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