Stage IV Non-small Cell Lung Cancer Clinical Trial
Official title:
Impacts of Exercise on Prognostic Biomarkers in Lung Cancer Patients
Verified date | February 2016 |
Source | University of Wisconsin, Madison |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 21 |
Est. completion date | February 2016 |
Est. primary completion date | July 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Wisconsin, Madison | Madison | Wisconsin |
United States | UW Health Oncology - 1 South Park | Madison | Wisconsin |
Lead Sponsor | Collaborator |
---|---|
University of Wisconsin, Madison | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in biomarkers of inflammation | 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. | Baseline up to 8 weeks | |
Primary | Change in oxidative damage as indicated by serum 8-hydroxydeoxyguanosine (8-oh-dG) | 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. | Baseline up to 8 weeks | |
Primary | Change in time to walk 400 m | 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. | Baseline up to 8 weeks | |
Primary | Change in physical well-being scores on the Functional Assessment of Cancer Therapy-Lung (FACT-L) | 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. | Baseline up to 8 weeks | |
Primary | Change in functional well-being scores on the FACT-L | 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. | Baseline up to 8 weeks | |
Secondary | Change in stress scores on the SF-36 | 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. | Baseline up to 8 weeks | |
Secondary | Change in quality-of-life scores on the SF-36 | 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. | Baseline up to 8 weeks |
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