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| Name | Class |
|---|---|
| Copenhagen University Hospital - Rigshospitalet, Department of Occupational Therapy and Physiotherapy | UNKNOWN |
| Copenhagen University Hospital at Herlev | OTHER |
| University Hospital Bispebjerg and Frederiksberg |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Patients in the intervention groups will receive neoadjuvant, adjuvant or first line palliative chemotherapy (for metastatic disease). In addition, all patients will undergo three months' targeted specialized physical group-based exercise and Comprehensive Geriatric Assessment with corresponding interventions |
|
| Usual care group | No Intervention | Patients in the usual care groups will receive standard treatment with neoadjuvant, adjuvant or first line palliative chemotherapy (for metastatic disease). If the patients have other health complaints, these will, as current standard procedure, be treated by oncologist or by referral to general practitioner |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Dynamic Gait Index (DGI) | 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 | Three months |
| 30 second Sit-to-Stand Test (30STS) | Between-group difference in lower limb muscle strength and endurance | Three months |
| Measure | Description | Time Frame |
|---|---|---|
| Falls | Self-reported falls | Baseline, two, four, six, eight, ten, twelve, fourteen, sixteen, eighteen, twenty, twenty-two, and twenty-four weeks |
| Hospital contacts due to falls | Hospital contacts due to falls |
| Measure | Description | Time Frame |
|---|---|---|
| Walking speed | Changes in walking speed using 10 meter walk test measuring gaitspeed in meters per second | Baseline, three and six months |
| Postural control | Changes in postural control (standing balance) using HUR SmartBalance platform |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Katrine S Piper, PhD-Student | Contact | +4551156140 | katrine.storm.piper@regionh.dk | |
| Jan Christensen, PhD | Contact | jan.christensen.02@regionh.dk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Copenhagen University Hospital - Rigshospitalet | Not yet recruiting | Copenhagen | 2400 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38631243 | Derived | Piper KS, Suetta C, Schou JV, Ryg J, Andersen HE, Langevad LV, Evering D, Mikkelsen MK, Lund C, Christensen J. The SaVe project - Sarcopenia and Vertigo in aging patients with colorectal cancer: A study protocol for three randomized controlled trials. J Geriatr Oncol. 2024 May;15(4):101770. doi: 10.1016/j.jgo.2024.101770. Epub 2024 Apr 16. |
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On reasonable request
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| Odense University Hospital, Department of Geriatric Medicine | UNKNOWN |
| Amager Hospital | OTHER |
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Investigator = Statistician
|
| Baseline, three and six months |
| Balance disabilities/dizziness | 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 | Baseline, three and six months |
| Fear of falling | 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 | Baseline, three and six months |
| Health related quality of life | 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 | Baseline, three and six months |
| Peripheral nerve function | Changes in peripheral nerve function using biothesiometer mesured in 0-50 volts. Higher volts means worse outcome | Baseline, three and six months |
| Autonomic function | Changes in autonomic function using Vagus device | Baseline, three and six months |
| Chemotherapy induced peripheral neuropathy | 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 | Baseline, three and six months |
| Muscle strength | Changes in muscle strength using HUR Leg Press Rehab performance recorder measuring weight in kilograms | Baseline, three and six months |
| Body composition | Changes in body composition using DXA | Baseline, three and six months |
| Muscle strength | Changes in muscle strength using handgrip test measuring weight in kilograms | Baseline, three and six months |
| Baseline, three and six months |
| Vestibular function | Changes in peripheral vestibular function using Video Head Impulse Test (vHIT) | Baseline, three and six months |
| Orthostatic blood pressure | Changes in orthostatic blood pressure measured from lying to standing and every minute for five minutes | Baseline, three and six months |
| Body composition | Changes in body composition using bioimpedance (BIA) | Baseline, three and six months |
| Muscle quality | Changes in muscle quality using ultrasound | Baseline and three months |
| Frailty | Presence of frailty using Geriatric-8 (G8) scored on a 0-17 point scale. Higher score means better outcome | Baseline |
| Frailty | Presence of frailty using Clinical Frailty Scale (CFS) scored on a 1-9 point scale. Higher score means worse outcome | Baseline |
| Activity level | Description of activity level using activity tracker | Baseline and three months |
| Cessation of chemotherapy | Description of cessation of chemotherapy | After 6, 12, and 24 weeks (from baseline) |
| Prescribed rehabilitation plan | Recording of exercise through a prescribed rehabilitation plan | Follow-up at 1, 2, 3, and 5 years |
| Overall survival | Recording of overall survival | Follow-up at 1, 2, 3, and 5 years |
| Hospitalisations | Recording of hospitalisations | Follow-up at 1, 2, 3, and 5 years |
| Progression of cancer | Recording of progression of cancer | Follow-up at 1, 2, 3, and 5 years |
| Recurrence of cancer | Recording of recurrence of cancer | Follow-up at 1, 2, 3, and 5 years |
| Biomarkers of sarcopenia and inflammation | 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. | Baseline, three and six months |
| Vision | Measurement of vision using a Snellen chart | Baseline |
| Copenhagen University Hospital - Herlev and Gentofte Hospital | Recruiting | Herlev | 2730 | Denmark |
|
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D055948 | Sarcopenia |
| D014717 | Vertigo |
| D009369 | Neoplasms |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D015837 | Vestibular Diseases |
| D007759 | Labyrinth Diseases |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D001519 | Behavior |
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