The SaVe Project-Sarcopenia and Vertigo in Aging Patients With Colorectal Cancer
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Phase 3 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Intervention group Patients in the intervention groups will receive 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 |
Other: Targeted 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
|
| No Intervention: Usual care group Patients in the usual care groups will receive standard treatment with 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 |
Outcome Measures
Primary Outcome Measures
- Dynamic Gait Index (DGI) [Three months]
Between-group difference in change in walking balance assessed with Dynamic Gait Index (DGI)
Secondary Outcome Measures
- Falls [Baseline, three and six months]
Self-reported falls
- Hospital contacts due to falls [Baseline, three and six months]
Hospital contacts due to falls
- 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)
- Fear of falling [Baseline, three and six months]
Changes in fear of falling using the patient reported outcome measure Falls Efficacy Scale International (FES-I)
- 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
- Peripheral nerve function [Baseline, three and six months]
Changes in peripheral nerve function using biothesiometer
- Autonomic function [Baseline, three and six months]
Changes in autonomic function using Vagus device
- 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
- Muscle strength [Baseline, three and six months]
Changes in muscle strength using HUR Leg Press Rehab performance recorder, handgrip test and 30 second chair stand test
- Body composition [Baseline, three and six months]
Changes in body composition using DXA
Other Outcome Measures
- Walking speed [Baseline, three and six months]
Changes in walking speed using 10 meter walk test
- 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)
- Gait analysis [Baseline, three and six months]
Changes in gait quality regarding balance using a motion tracker
- 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
- Muscle quality [Baseline and three months]
Changes in muscle quality using muscle biopsy
- Muscle quality [Baseline and three months]
Changes in muscle quality using ultrasound
- Frailty [Baseline]
Presence of frailty using Geriatric-8 (G8)
- Frailty [Baseline]
Presence of frailty using Clinical Frailty Scale (CFS)
- 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
- Exercise habits [Follow-up at 1, 2, 3, and 5 years]
Recording of exercise habits
- 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
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Meet the criteria of the oncological departments of receiving adjuvant chemotherapy or first line palliative chemotherapy for colorectal cancer
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≥65 years of age at the time of signing the informed consent form
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Able to speak and read Danish, and to provide a signed informed consent form
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Have an Eastern Cooperative Oncology Group (ECOG) performance status score of ≤2
Exclusion Criteria:
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Other malignant disease except from basal cell carcinoma and carcinoma in situ cervices uteri within five years
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Have recieved chemotherapy within five years
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Severe physical disability that hinders physical exercise
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Dementia, psychotic disorders, or other cognitive diseases or conditions that hinder participation in a clinical exercise-based trial
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Inability to sign informed content
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Patients who have had a consultation in the geriatric outpatient clinic within the past six months
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Rigshospitalet, Denmark
- Copenhagen University Hospital - Rigshospitalet, Department of Occupational Therapy and Physiotherapy
- Copenhagen University Hospital - Herlev and Gentofte Hospital, Department of Medicine
- Copenhagen University Hospital - Herlev and Gentofte Hospital, Department of Oncology
- Copenhagen University Hospital - Bispebjerg and Frederiksberg Hospital
- Odense University Hospital, Department of Geriatric Medicine
- Copenhagen University Hospital - Amager and Hvidovre Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- H-22064206