Impacts of Exercise on Prognostic Biomarkers in Lung Cancer Patients

Not Applicable

Completed

• Conditions: Stage IIB Non-small Cell Lung Cancer; Healthy, no Evidence of Disease; Recurrent Small Cell Lung Cancer; Stage IIIA Non-small Cell Lung Cancer; Stage IIIB Non-small Cell Lung Cancer; Stage IB Non-small Cell Lung Cancer; Stage IIA Non-small Cell Lung Cancer; Stage IV Non-small Cell Lung Cancer; Extensive Stage Small Cell Lung Cancer; Limited Stage Small Cell Lung Cancer
• Interventions: Procedure: standard follow-up care; Behavioral: exercise intervention; Procedure: quality-of-life assessment; Other: laboratory biomarker analysis

• Registration Number: NCT01999881
• Lead Sponsor: University of Wisconsin, Madison

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.

Study Timeline

• Study First Submitted: 2013-11-25
• Study First Submitted QC: 2013-11-25
• Study Start: 2013-12
• Study First Posted: 2013-12-03
• Primary Completion: 2015-07
• Status Verified: 2016-02
• Study Completion: 2016-02
• Last Update Submitted: 2019-11-14
• Last Update Posted: 2019-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm II (usual care)	standard follow-up care	Patients and their support persons undergo the usual care over 8 weeks.
Arm II (usual care)	laboratory biomarker analysis	Patients and their support persons undergo the usual care over 8 weeks.
Arm A (aerobic and exercise training)	exercise intervention	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 UWHC and 3 days a week at home over 8 weeks.
Arm A (aerobic and exercise training)	quality-of-life assessment	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 UWHC and 3 days a week at home over 8 weeks.
Arm A (aerobic and exercise training)	laboratory biomarker analysis	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 UWHC and 3 days a week at home over 8 weeks.
Arm II (usual care)	quality-of-life assessment	Patients and their support persons undergo the usual care over 8 weeks.

Primary Outcome Measures

Name	Time	Method
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 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 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.
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.

Secondary Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (2)

University of Wisconsin, Madison; 🇺🇸 Madison, Wisconsin, United States

UW Health Oncology - 1 South Park; 🇺🇸 Madison, Wisconsin, United States