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

Study Overview
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Brief Summary
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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

Detailed Description
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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.

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

Conditions
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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

Intervention / Treatment
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* Other: Targeted specialized physical group-based exercise and Comprehensive Geriatric Assessement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Meet the criteria of the oncological departments of receiving adjuvant chemotherapy 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: Other malignant disease except from basal cell carcinoma and carcinoma in situ cervices uteri within five years Have recieved chemotherapy within five years 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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>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<br>* Vestibular rehabilitation, balance- and progressive resistance training for three months' three times/week and Comprehensive Geriatric Assessement including corresponding interventions<br>|
| No Intervention: Usual care group<br>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 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dynamic Gait Index (DGI) | Between-group difference in change in walking balance assessed with Dynamic Gait Index (DGI) | Three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Falls | Self-reported falls | Baseline, three and six months | 
| Hospital contacts due to falls | Hospital contacts due to falls | 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) | Baseline, three and six months | 
| Fear of falling | Changes in fear of falling using the patient reported outcome measure Falls Efficacy Scale International (FES-I) | 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 | Baseline, three and six months | 
| Peripheral nerve function | Changes in peripheral nerve function using biothesiometer | 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 | Baseline, three and six months | 
| Muscle strength | Changes in muscle strength using HUR Leg Press Rehab performance recorder, handgrip test and 30 second chair stand test | Baseline, three and six months | 
| Body composition | Changes in body composition using DXA | Baseline, three and six months |