The SaVe Project-Sarcopenia and Vertigo in Aging Patients With Colorectal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 4
- 主要终点
- 30 second Sit-to-Stand Test (30STS)
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Investigator = Statistician
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
30 second Sit-to-Stand Test (30STS)
时间窗: Three months
Between-group difference in lower limb muscle strength and endurance
Dynamic Gait Index (DGI)
时间窗: 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
次要结局
- Hospital contacts due to falls(Baseline, three and six months)
- Body composition(Baseline, three and six months)
- Fear of falling(Baseline, three and six months)
- Health related quality of life(Baseline, three and six months)
- Peripheral nerve function(Baseline, three and six months)
- Autonomic function(Baseline, three and six months)
- Falls(Baseline, two, four, six, eight, ten, twelve, fourteen, sixteen, eighteen, twenty, twenty-two, and twenty-four weeks)
- Balance disabilities/dizziness(Baseline, three and six months)
- Chemotherapy induced peripheral neuropathy(Baseline, three and six months)
- Muscle strength(Baseline, three and six months)
研究者
Jan Christensen
Senior researcher, Head of research
Rigshospitalet, Denmark