Impacts of Exercise on Prognostic Biomarkers in Lung Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 4
- 主要终点
- Change in biomarkers of inflammation
研究概览
简要总结
This randomized pilot clinical trial studies exercise intervention in improving quality of life and exercise capacity and reducing inflammation and oxidative stress in patients with lung cancer and their support persons. Exercise therapy may help improve quality of life, may increase exercise capacity, and may reduce inflammation and oxidative stress in patients with lung cancer and their supporters.
详细描述
PRIMARY OBJECTIVES:
I. Determine the effect of an eight-week exercise intervention on biomarkers of inflammation, oxidative stress, exercise capacity, and quality of life in lung cancer patients.
SECONDARY OBJECTIVES:
I. Determine the effect of an eight-week exercise intervention on markers of stress and quality of life in the support person of lung cancer patients.
OUTLINE: Participants are randomized to 1 of 2 arms.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •LUNG CANCER PATIENTS: A confirmed diagnosis of any stage lung cancer (non-small cell lung cancer [NSCLC] or small cell lung cancer [SCLC])
- •LUNG CANCER PATIENTS: Can be receiving any type of treatment (chemotherapy, radiation therapy, both or neither) are eligible
- •LUNG CANCER PATIENTS: Able to understand and read in English sufficiently to adequately complete informed consent to participate and to complete the questionnaires
- •LUNG CANCER PATIENTS: For patients treated with curative intent, and who have not relapsed, they must be within 1 year of their diagnosis of lung cancer (determined by date of diagnostic pathology sample)
- •SUPPORT PERSONS: Able to understand and read in English sufficiently to adequately complete informed consent to participate and to complete the questionnaires
排除标准
- •LUNG CANCER PATIENTS: Symptomatic heart disease including congestive heart failure or arrhythmia
- •LUNG CANCER PATIENTS: Documented myocardial infarction in the last three months
- •LUNG CANCER PATIENTS: Central nervous system (CNS) metastases that results in impaired ability to participate in an exercise program at the discretion of the study physician
- •LUNG CANCER PATIENTS: Any psychological or physical disease that would impair or prevent participation in an exercise program at the discretion of the study physician
- •LUNG CANCER PATIENTS: Cognitive or reading impairments that would preclude them from completing questionnaires
- •LUNG CANCER PATIENTS: Current participation in an exercise program
- •SUPPORT PERSONS: Symptomatic heart disease including congestive heart failure or arrhythmia
- •SUPPORT PERSONS: Documented myocardial infarction in the last three months
- •SUPPORT PERSONS: Cognitive or reading impairments that would preclude them from completing questionnaires
结局指标
主要结局
Change in biomarkers of inflammation
时间窗: Baseline up to 8 weeks
Descriptive statistics will be calculated and compared between the two treatment groups at baseline using unpaired t-tests and Chi-Square analyses. A two-way analysis of variance will be used to examine the effects of the treatment over time.
Change in oxidative damage as indicated by serum 8-hydroxydeoxyguanosine (8-oh-dG)
时间窗: Baseline up to 8 weeks
Descriptive statistics will be calculated and compared between the two treatment groups at baseline using unpaired t-tests and Chi-Square analyses. A two-way analysis of variance will be used to examine the effects of the treatment over time.
Change in time to walk 400 m
时间窗: Baseline up to 8 weeks
Descriptive statistics will be calculated and compared between the two treatment groups at baseline using unpaired t-tests and Chi-Square analyses. A two-way analysis of variance will be used to examine the effects of the treatment over time.
Change in physical well-being scores on the Functional Assessment of Cancer Therapy-Lung (FACT-L)
时间窗: Baseline up to 8 weeks
Descriptive statistics will be calculated and compared between the two treatment groups at baseline using unpaired t-tests and Chi-Square analyses. A two-way analysis of variance will be used to examine the effects of the treatment over time.
Change in functional well-being scores on the FACT-L
时间窗: Baseline up to 8 weeks
Descriptive statistics will be calculated and compared between the two treatment groups at baseline using unpaired t-tests and Chi-Square analyses. A two-way analysis of variance will be used to examine the effects of the treatment over time.
次要结局
- Change in stress scores on the SF-36(Baseline up to 8 weeks)
- Change in quality-of-life scores on the SF-36(Baseline up to 8 weeks)