Balance Training, Cancer, Chemotherapy, Chemotherapy-induced Peripheral Neuropathy, Colorectal Cancer, Comprehensive Geriatric Assessment, Elderly, Exercise, Frail, Geriatric, Geriatric Oncology, Individualised, Older Adults, Oncologic Complications, Personal Medicine, Postural Stability, Pragmatic Trial, Rehabilitation, Resistance Training, Sarcopenia, Vertigo, Vestibular Rehabilitation
Conditions
Brief 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
Detailed 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.
Interventions
OTHERTargeted specialized physical group-based exercise and Comprehensive Geriatric Assessement
Vestibular rehabilitation, balance- and progressive resistance training for three months' three times/week and Comprehensive Geriatric Assessement including corresponding interventions
Sponsors
Copenhagen University Hospital - Rigshospitalet, Department of Occupational Therapy and Physiotherapy
Copenhagen University Hospital at Herlev
Copenhagen University Hospital - Bispebjerg and Frederiksberg Hospital
Odense University Hospital, Department of Geriatric Medicine
Copenhagen University Hospital - Amager and Hvidovre Hospital
Rigshospitalet, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Investigator = Statistician
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dynamic Gait Index (DGI) | 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 |
| 30 second Sit-to-Stand Test (30STS) | Three months | Between-group difference in lower limb muscle strength and endurance |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Balance disabilities/dizziness | 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 |
| Fear of falling | 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 |
| Health related quality of life | 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 |
| Peripheral nerve function | Baseline, three and six months | Changes in peripheral nerve function using biothesiometer mesured in 0-50 volts. Higher volts means worse outcome |
| Falls | Baseline, two, four, six, eight, ten, twelve, fourteen, sixteen, eighteen, twenty, twenty-two, and twenty-four weeks | Self-reported falls |
| Chemotherapy induced peripheral neuropathy | 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 |
| Muscle strength | Baseline, three and six months | Changes in muscle strength using HUR Leg Press Rehab performance recorder measuring weight in kilograms |
| Body composition | Baseline, three and six months | Changes in body composition using DXA |
| Autonomic function | Baseline, three and six months | Changes in autonomic function using Vagus device |
| Hospital contacts due to falls | Baseline, three and six months | Hospital contacts due to falls |
Other
| Measure | Time frame | Description |
|---|---|---|
| Progression of cancer | Follow-up at 1, 2, 3, and 5 years | Recording of progression of cancer |
| Recurrence of cancer | Follow-up at 1, 2, 3, and 5 years | Recording of recurrence of cancer |
| Walking speed | Baseline, three and six months | Changes in walking speed using 10 meter walk test measuring gaitspeed in meters per second |
| Vision | Baseline | Measurement of vision using a Snellen chart |
| Biomarkers of sarcopenia and inflammation | 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. |
| Postural control | Baseline, three and six months | Changes in postural control (standing balance) using HUR SmartBalance platform |
| Vestibular function | Baseline, three and six months | Changes in peripheral vestibular function using Video Head Impulse Test (vHIT) |
| Orthostatic blood pressure | Baseline, three and six months | Changes in orthostatic blood pressure measured from lying to standing and every minute for five minutes |
| Body composition | Baseline, three and six months | Changes in body composition using bioimpedance (BIA) |
| Muscle quality | Baseline and three months | Changes in muscle quality using ultrasound |
| Frailty | Baseline | Presence of frailty using Geriatric-8 (G8) scored on a 0-17 point scale. Higher score means better outcome |
| Activity level | Baseline and three months | Description of activity level using activity tracker |
| Cessation of chemotherapy | After 6, 12, and 24 weeks (from baseline) | Description of cessation of chemotherapy |
| Prescribed rehabilitation plan | Follow-up at 1, 2, 3, and 5 years | Recording of exercise through a prescribed rehabilitation plan |
| Overall survival | Follow-up at 1, 2, 3, and 5 years | Recording of overall survival |
| Hospitalisations | Follow-up at 1, 2, 3, and 5 years | Recording of hospitalisations |
Countries
Denmark
Contacts
Primary ContactKatrine S Piper, PhD-Student
Backup ContactJan Christensen, PhD
Outcome results
None listed