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

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

Recruiting
65 years and older
All
Phase N/A

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Overview

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

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.

Eligibility

Inclusion Criteria:

  • Meet the criteria of the oncological departments of receiving neoadjuvant, adjuvant or 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 Criteria:

  • Chemotherapy treatment within two years and sequelae of neuropathy, or symptoms of dizziness or vertigo, or balance disturbance
  • Severe physical disability that hinders physical exercise
  • Dementia, psychotic disorders, or other cognitive diseases or conditions that hinder participation in a clinical exercise-based trial
  • Inability to sign informed content
  • Patients who have had a consultation in the geriatric outpatient clinic within the past six months

Study details
    Colorectal Cancer
    Oncologic Complications
    Comprehensive Geriatric Assessment
    Vestibular Rehabilitation
    Geriatric Oncology
    Sarcopenia
    Vertigo
    Cancer
    Rehabilitation
    Exercise
    Geriatric
    Elderly
    Frail
    Older Adults
    Chemotherapy
    Chemotherapy-induced Peripheral Neuropathy
    Resistance Training
    Balance Training
    Postural Stability
    Pragmatic Trial
    Personal Medicine
    Individualised

NCT05710809

Rigshospitalet, Denmark

15 May 2026

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