Extensive Stage Small Cell Lung Cancer, Healthy, no Evidence of Disease, Limited Stage Small Cell Lung Cancer, Recurrent Non-small Cell Lung Cancer, Recurrent Small Cell Lung Cancer, Stage IA Non-small Cell Lung Cancer, Stage IB Non-small Cell Lung Cancer, Stage IIA Non-small Cell Lung Cancer, Stage IIB Non-small Cell Lung Cancer, Stage IIIA Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer
Conditions
Brief 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.
Detailed 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.
Interventions
BEHAVIORALexercise intervention
Receive aerobic and exercise intervention
PROCEDUREstandard follow-up care
Receive usual care
PROCEDUREquality-of-life assessment
Ancillary studies
OTHERlaboratory biomarker analysis
Correlative studies
Sponsors
National Cancer Institute (NCI)
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in oxidative damage as indicated by serum 8-hydroxydeoxyguanosine (8-oh-dG) | 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) | 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 | 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 biomarkers of inflammation | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in quality-of-life scores on the SF-36 | 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 stress scores on the SF-36 | 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. |
Countries
United States
Outcome results
None listed