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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01999881
Other study ID # UW13034
Secondary ID NCI-2013-0218520
Status Completed
Phase N/A
First received
Last updated
Start date December 2013
Est. completion date February 2016

Study information

Verified date February 2016
Source University of Wisconsin, Madison
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.

ARM A: Patients and their support persons undergo a supervised combined aerobic exercise comprising walking, cycling, or video-based aerobics and strength training using resistance bands for 40 minutes 2 days a week at the University of Wisconsin Hospital and Clinic (UWHC) and 3 days a week at home over 8 weeks.

ARM B: Patients and their support persons undergo the usual care over 8 weeks.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
exercise intervention
Receive aerobic and exercise intervention
Procedure:
standard follow-up care
Receive usual care
quality-of-life assessment
Ancillary studies
Other:
laboratory biomarker analysis
Correlative studies

Locations

Country Name City State
United States University of Wisconsin, Madison Madison Wisconsin
United States UW Health Oncology - 1 South Park Madison Wisconsin

Sponsors (2)

Lead Sponsor Collaborator
University of Wisconsin, Madison National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

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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