The SaVe Project-Sarcopenia and Vertigo in Aging Patients With Colorectal Cancer

Last updated: April 2, 2025
Sponsor: Rigshospitalet, Denmark
Overall Status: Active - Recruiting

Phase

N/A

Condition

Colon Cancer; Rectal Cancer

Chemotherapy

Colorectal Cancer

Treatment

Targeted specialized physical group-based exercise and Comprehensive Geriatric Assessement

Clinical Study ID

NCT05710809
H-22064206
  • Ages > 65
  • All Genders

Study Summary

The goal of this clinical trial is to learn about the cause of dizziness and decline in walking ability in in older adults ≥65 years during chemotherapy treatment for colorectal cancer. Another goal is to investigate if a comprehensive geriatric assessment and three months' specialized physical group-based exercise three times/week can counteract muscle weakness, vertigo, instability, impaired walking balance, and neuropathy

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Meet the criteria of the oncological departments of receiving neoadjuvant, adjuvantor first line palliative chemotherapy for colorectal cancer

  • ≥65 years of age at the time of signing the informed consent form

  • Able to speak and read Danish, and to provide a signed informed consent form

  • Have an Eastern Cooperative Oncology Group (ECOG) performance status score of ≤2

Exclusion

Exclusion Criteria:

  • Chemotherapy treatment within two years and sequelae of neuropathy, or symptoms ofdizziness or vertigo, or balance disturbance

  • Severe physical disability that hinders physical exercise

  • Dementia, psychotic disorders, or other cognitive diseases or conditions that hinderparticipation in a clinical exercise-based trial

  • Inability to sign informed content

  • Patients who have had a consultation in the geriatric outpatient clinic within thepast six months

Study Design

Total Participants: 150
Treatment Group(s): 1
Primary Treatment: Targeted specialized physical group-based exercise and Comprehensive Geriatric Assessement
Phase:
Study Start date:
February 20, 2023
Estimated Completion Date:
September 30, 2027

Study Description

Frequent adverse effects of chemotherapy in older adults are nausea and fatigue, but our research group have discovered a problem with many also suffering from sarcopenia, vertigo, dizziness, and peripheral neuropathy (CIPN) leading to balance and walking impairments causing increased risk of falls. Moreover, these symptoms are often underreported with inadequate awareness among health professionals leading to deficient focus on the need for targeted rehabilitation. A comprehensive geriatric assessment (CGA) can increase the number of frail, older patients completing chemotherapy and CGA-based interventions can decrease chemotherapy toxicity and improve health-related quality of life (HRQoL). Physical exercise has been shown to reduce muscle weakness, vertigo, dizziness, and impaired balance among older adults requiring limited resources. Therefore, this project aims to investigate the effectiveness of CGA and physical exercise to counteract muscle weakness, vertigo, instability, and impaired walking balance, during chemotherapy and to investigate the interaction between vertigo, postural stability and walking performance, and neuropathy and the prevalence of sarcopenia. The activities of specialized physical exercise planned in this intervention will, as hypothesized, result in a change in muscle strength, walking balance, self-perceived balance disabilities/dizziness, and fear of falling along with changes in peripheral nerve function and autonomic function and severity of CIPN which are the outcomes of this study. Accordingly, expectations are that this intervention will affect the HRQoL among older cancer patients with vertigo and walking impairments and reduce the number of falls and hospital admissions leading to a socioeconomic benefit.

Connect with a study center

  • Copenhagen University Hospital - Rigshospitalet

    Copenhagen, 2400
    Denmark

    Site Not Available

  • Copenhagen University Hospital - Herlev and Gentofte Hospital

    Herlev, 2730
    Denmark

    Active - Recruiting

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