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临床试验/NCT04321187
NCT04321187已完成不适用

Influence of Radiotherapy on the Dynamics of Aging in Prostate Cancer Patients

Medical University of Graz1 个研究点 分布在 1 个国家目标入组 314 人开始时间: 2019年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
314
试验地点
1
主要终点
Mobility

研究概览

简要总结

Previous studies have reported that cancer survivors develop age-related chronic conditions like frailty, sarcopenia, cardiac dysfunction, and cognitive impairment earlier and/or at a greater burden than similarly aged individuals never diagnosed with cancer or exposed to cancer therapies.

However, the knowledge about aging-associated consequences of cancer treatment and the processes that underlie differential responses to therapy is very limited. In 2018, a think tank established by the National Cancer Institute has defined various research needs to expand the evidence base for aging-related consequences of cancer treatment, such as studies to examine aging-related processes that include regularly performed assessments capturing factors associated with physical function or studies to elucidate pathways that lead to the emergence of aging phenotypes and to understand the relationships between biomarkers of aging and functional outcomes in cancer survivors. In addition, study inclusion of older adults with comorbidities and higher levels of frailty has been proposed to achieve an improved understanding of functional outcomes at any age.

Hypotheses / objectives We hypothesize that prostate cancer radiotherapy accelerates aging-related processes, furthermore, aging-related biomarkers may predict functional outcomes and represent early indicators of aging phenotypes. Primary objectives of the proposed study are the determination of the aging-related consequences of radiotherapy in prostate cancer patients and the evaluation of the relationship between biomarkers of aging and age-related clinical conditions.

详细描述

Systematic evaluations of functional and cognitive status, comorbidities, health status, mobility, nutritional status, psychological status, and social circumstances as well as measurements of cellular senescence and chronic inflammation will be performed in a cohort of prostate cancer patients at baseline (before radiotherapy), at the end of radiotherapy and at follow-up intervals thereafter. The evaluation of aging-related biomarkers will include determination of markers of cellular senescence and markers of systemic inflammation. The correlation between genetic variants modulating telomere length and the risk of developing age-related phenotypes will also be analyzed.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
70 Years 至 100 Years(Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Prostate cancer
  • Candidate to definitive radiation treatment
  • Local or locally advanced disease
  • Aged ≥ 65 years
  • Informed consent

排除标准

  • Unable to give written informed consent
  • Metastatic disease

结局指标

主要结局

Mobility

时间窗: 2 years

Mobility measured by the Timed up and go test (≥12 seconds to complete the Timed up and go test indicates mobility impairment and worse outcome)

Number of medications taken

时间窗: 2 years

Polypharmacy represents an aging related condition (high number of medication taken indicates worse outcome)

Functionality - activities of daily living

时间窗: 2 years

Functional decline measured by Activities of Daily Living examination (range, 0-6; high values indicate high functionality and improved outcome)

Functionality - instrumental activities of daily living

时间窗: 2 years

Functional decline measured by the Instrumental Activities of Daily Living examination (range, 0-8; high values indicate high functionality and improved outcome)

Cognitive disorder

时间窗: 2 years

Cognitive disorder measured by the Mini-Mental State Examination (range, 0-30; high values indicate normal cognition and improved outcome)

Comorbidities

时间窗: 2 years

Comorbidities measured by the Charlson comorbidity index (range, 0-37; high score indicates high rate of comorbidities and worse outcome)

Mental disorder

时间窗: 2 years

Mental disorder measured by the Geriatric depression scale (range, 0-30; higher values indicate depression and worse outcome)

次要结局

  • Radiation induced toxicity(10 years)

研究者

发起方
Medical University of Graz
申办方类型
Other
责任方
Sponsor

研究点 (1)

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