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NCT Number: NCT05710809

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

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Targeted specialized physical group-based exercise and Comprehensive Geriatric Assessement

Other

Vestibular rehabilitation, balance- and progressive resistance training for three months' three times/week and Comprehensive Geriatric Assessement including corresponding interventions

Primary outcomes

  1. Dynamic Gait Index (DGI)

    Time frame: Three months

    Between-group difference in change in walking balance assessed with Dynamic Gait Index (DGI) scored on a 0-24 point total scale. Higher score means better outcome

  2. 30 second Sit-to-Stand Test (30STS)

    Time frame: Three months

    Between-group difference in lower limb muscle strength and endurance

Secondary outcomes

  1. Falls

    Time frame: Baseline, two, four, six, eight, ten, twelve, fourteen, sixteen, eighteen, twenty, twenty-two, and twenty-four weeks

    Self-reported falls

  2. Hospital contacts due to falls

    Time frame: Baseline, three and six months

    Hospital contacts due to falls

  3. Balance disabilities/dizziness

    Time frame: Baseline, three and six months

    Changes in self-perceived balance disabilities/dizziness using the patient reported outcome measure Dizziness Handicap Inventory (DHI) scored on a 0-100 point total scale. Higher score means worse outcome

  4. Fear of falling

    Time frame: Baseline, three and six months

    Changes in fear of falling using the patient reported outcome measure Short Falls Efficacy Scale International (Short FES-I) scored on a 0-28 point total scale. Higher score means worse outcome

  5. Health related quality of life

    Time frame: Baseline, three and six months

    Changes in health related quality of life using the patient reported outcome measure EORTC QLQ-C30. The total score is converted to a 0-100 scale. Higher score means better outcome

  6. Peripheral nerve function

    Time frame: Baseline, three and six months

    Changes in peripheral nerve function using biothesiometer mesured in 0-50 volts. Higher volts means worse outcome

  7. Autonomic function

    Time frame: Baseline, three and six months

    Changes in autonomic function using Vagus device

  8. Chemotherapy induced peripheral neuropathy

    Time frame: Baseline, three and six months

    Severity of chemotherapy induced peripheral neuropathy using the patient reported outcome measure EORTC QLQ-CIPN-20. The total score is converted to a 0-100 scale. Higher score means worse outcome

  9. Muscle strength

    Time frame: Baseline, three and six months

    Changes in muscle strength using HUR Leg Press Rehab performance recorder measuring weight in kilograms

  10. Body composition

    Time frame: Baseline, three and six months

    Changes in body composition using DXA

  11. Muscle strength

    Time frame: Baseline, three and six months

    Changes in muscle strength using handgrip test measuring weight in kilograms

Other outcomes

  1. Walking speed

    Time frame: Baseline, three and six months

    Changes in walking speed using 10 meter walk test measuring gaitspeed in meters per second

  2. Postural control

    Time frame: Baseline, three and six months

    Changes in postural control (standing balance) using HUR SmartBalance platform

  3. Vestibular function

    Time frame: Baseline, three and six months

    Changes in peripheral vestibular function using Video Head Impulse Test (vHIT)

  4. Orthostatic blood pressure

    Time frame: Baseline, three and six months

    Changes in orthostatic blood pressure measured from lying to standing and every minute for five minutes

  5. Body composition

    Time frame: Baseline, three and six months

    Changes in body composition using bioimpedance (BIA)

  6. Muscle quality

    Time frame: Baseline and three months

    Changes in muscle quality using ultrasound

  7. Frailty

    Time frame: Baseline

    Presence of frailty using Geriatric-8 (G8) scored on a 0-17 point scale. Higher score means better outcome

  8. Frailty

    Time frame: Baseline

    Presence of frailty using Clinical Frailty Scale (CFS) scored on a 1-9 point scale. Higher score means worse outcome

  9. Activity level

    Time frame: Baseline and three months

    Description of activity level using activity tracker

  10. Cessation of chemotherapy

    Time frame: After 6, 12, and 24 weeks (from baseline)

    Description of cessation of chemotherapy

  11. Prescribed rehabilitation plan

    Time frame: Follow-up at 1, 2, 3, and 5 years

    Recording of exercise through a prescribed rehabilitation plan

  12. Overall survival

    Time frame: Follow-up at 1, 2, 3, and 5 years

    Recording of overall survival

  13. Hospitalisations

    Time frame: Follow-up at 1, 2, 3, and 5 years

    Recording of hospitalisations

  14. Progression of cancer

    Time frame: Follow-up at 1, 2, 3, and 5 years

    Recording of progression of cancer

  15. Recurrence of cancer

    Time frame: Follow-up at 1, 2, 3, and 5 years

    Recording of recurrence of cancer

  16. Biomarkers of sarcopenia and inflammation

    Time frame: Baseline, three and six months

    Biomarkers of sarcopenia and inflammation collected through blood samples. To determine concentration of inflammatory cytokines; High-sensitivity C-reactive Protein (hsCRP), tumour necrosis factor alpha (TNF- α), interleukin 6 (IL6), interleukin 13 (IL-13), and of muscle atrophy and muscle wasting (growth differentiation factor 11 (GDF11), and growth differentiation factor 15 (GDF-15). Blood samples are analysed by standard ELISA-analyses for plasma samples.

  17. Vision

    Time frame: Baseline

    Measurement of vision using a Snellen chart

Study contacts

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

Jan Christensen, PhD

CONTACT

[email protected]

Katrine S Piper, PhD-Student

CONTACT

[email protected]

+4551156140

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • Amager Hospital
  • Copenhagen University Hospital - Rigshospitalet, Department of Occupational Therapy and Physiotherapy
  • Copenhagen University Hospital at Herlev
  • Odense University Hospital, Department of Geriatric Medicine
  • University Hospital Bispebjerg and Frederiksberg

Registry information

Acronym: SaVe

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Feb 2, 2023
Registry last updated
Apr 6, 2025

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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