Strength and Aerobic Training in Elderly Lymphoma Patients During Chemotherapy and Its Impact on Treatment Outcomes, Patients Functioning and Biological Markers of Ageing
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 主要终点
- DNA methylation
研究概览
简要总结
Frailty, one of geriatric syndromes, is considered a major obstacle for recovery from physiological stress. Such stress is imposed on patients with cancer by virtue of the disease itself but even more so by the treatment. Moreover, malignancy and chemotherapy both cause accelerated loss of muscle mass, deconditioning, frailty and negative outcomes. Several studies showed that chemotherapy accelerates ageing.
Muscle mass reserve was found to be a major predictor of outcomes in patients treated with chemotherapy. Recently, several studies suggest that active muscle strength training during chemotherapy may decrease side effects, improves the ability to deliver intended doses of treatment and may even affect oncological outcomes.
In the proposed study we intend to assess the contribution of physical training to the well-being of chemotherapy treated older patients, assessed by molecular and physiological parameters.
We intend to recruit lymphoma patients above age of 70 and prospectively and randomly assign them to the intervention group (strength, aerobic and balance training during the chemotherapy) and control group (standard care with no special emphasis on physical activity during the treatment).
We will measure clinical outcomes such as treatment tolerance and effects as well as physiological outcomes (muscle strength and mass, elements activities of daily living) and laboratory markers of ageing such as DNA methylation, INK 4a expression, telomere length and serum levels of inteleukin 6, CRP among others.
Our hypothesis is that physical training will improve patients' ability to complete the treatment with fewer side effects, will provide them with better daily functioning and better muscle strength/function. We also hypothesize that the ageing process, as shown by laboratory senescence markers, will be attenuated in the intervention group.
详细描述
Introduction Rising life expectancy and an exponential correlation between age and cancer incidence brought about a new field of geriatric oncology. As patients above age 65 account for more than 60% of cancer diagnoses with octogenarians and even nonagenarians being not rare in oncology practice, a geriatric prospective becomes essential in the treatment process.
Frailty, a nebulous term, defined on the metabolic basis as "vicious circle of energetic dysregulation", is largely heterogeneous in younger elderly population, with some people being frail, others borderline -"prefrail" or even non-frail - "fit". Nevertheless, frailty becomes universal as senescence progresses, as it is tightly linked with physiological ageing and usually worsened by comorbidities. Elderly patients can seem fit and in good health but still be "sub-clinically" frail. The clinical significance is a gradual loss of ability to cope and recover from physiological stress.
Oncological patients are exposed to two major physiological stresses: the catabolic state induced by the disease and the chemotherapy challenge to tissues.
Curative-intent chemotherapy is usually withheld from very frail individuals but elderly patients deemed to be pre-frail or fit are frequently treated according to standard or mildly modified protocols, putting them at risk of slow or no recovery from drug related toxicity. Moreover, it was shown in other studies that chemotherapy itself accelerates senescence by stress related mechanisms and promotes muscle loss and frailty in younger individuals .
Numerous tools have been developed to try to measure frailty and help treatment decisions. Despite some differences, the main bulk of evaluated elements in all of those tools refer in some way to patient's ability to perform physical activity including muscle strength, walking speed, level of energy production and feeling tired, emphasizing the critical role of muscles in elderly general condition .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •70 years old and older
- •Newly diagnosed large B cell lymphoma, Hodgkin lymphoma or follicular lymphoma planned for at least 75% of full dose chemotherapy
- •preserved cognition or mild dementia
- •Ability to perform physical activity
排除标准
- 未提供
结局指标
主要结局
DNA methylation
时间窗: 6 month
blood tests
INK 4a expression
时间窗: 6 month
blood test
telomere length
时间窗: 6 month
blood tests
muscle strength and mass
时间窗: 6 month
evaluated by physiotherapists
elements activities of daily living
时间窗: 6 month
evaluated by physiotherapists
treatment tolerance
时间窗: 6 month
treatment dose density
serum levels of inteleukin 6
时间窗: 6 month
blood tests
CRP
时间窗: 6 month
blood tests
次要结局
未报告次要终点
研究者
IULIANA VAXMAN
principal investigator
Rabin Medical Center