Impacts of Exercise on Prognostic Biomarkers in Lung Cancer Patients

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53715
      • UW Health Oncology - 1 South Park
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin, Madison

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A (aerobic and exercise training); 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.	Other: laboratory biomarker analysis; Correlative studies; Procedure: quality-of-life assessment; Ancillary studies; Other Names: quality of life assessment; Behavioral: exercise intervention; Receive aerobic and exercise intervention
Active Comparator: Arm II (usual care); Patients and their support persons undergo the usual care over 8 weeks.	Other: laboratory biomarker analysis; Correlative studies; Procedure: quality-of-life assessment; Ancillary studies; Other Names: quality of life assessment; Procedure: standard follow-up care; Receive usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Toby Campbell, University of Wisconsin, Madison

Publications and helpful links

Helpful Links

• University of Wisconsin Carbone Cancer Center

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: November 25, 2013
• First Submitted That Met QC Criteria: November 25, 2013
• First Posted (Estimate): December 3, 2013

Study Record Updates

• Last Update Posted (Actual): November 18, 2019
• Last Update Submitted That Met QC Criteria: November 14, 2019
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Disease Attributes; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Recurrence; Small Cell Lung Carcinoma
• Other Study ID Numbers: UW13034 (Other Identifier: University of Wisconsin Carbone Cancer Center); P30CA014520 (U.S. NIH Grant/Contract); A534260 (Other Identifier: UW Madison); SMPH\MEDICINE\HEM-ONC (Other Identifier: UW Madison); 2013-0752 (Institutional Review Board); NCI-2013-02185 (Registry Identifier: NCI Trial ID)