Impacts of Exercise on Prognostic Biomarkers in Lung Cancer Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of Wisconsin, Madison
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01999881
First received: November 25, 2013
Last updated: March 18, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
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
Behavioral: exercise intervention
Procedure: standard follow-up care
Procedure: quality-of-life assessment
Other: laboratory biomarker analysis

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Impacts of Exercise on Prognostic Biomarkers in Lung Cancer Patients

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Change in biomarkers of inflammation [ Time Frame: Baseline up to 8 weeks ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline up to 8 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline up to 8 weeks ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline up to 8 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline up to 8 weeks ] [ Designated as safety issue: No ]
    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:
  • Change in stress scores on the SF-36 [ Time Frame: Baseline up to 8 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline up to 8 weeks ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 108
Study Start Date: December 2013
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Behavioral: exercise intervention
Receive aerobic and exercise intervention
Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
Other: laboratory biomarker analysis
Correlative studies
Active Comparator: Arm II (usual care)
Patients and their support persons undergo the usual care over 8 weeks.
Procedure: standard follow-up care
Receive usual care
Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
Other: laboratory biomarker analysis
Correlative studies

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01999881

Contacts
Contact: Toby Campbell, MD 608-263-3962 tcc@medicine.wisc.edu
Contact: Hilary Hernan 608-262-8158 hrhernan@medicine.wisc.edu

Locations
United States, Wisconsin
University of Wisconsin, Madison Recruiting
Madison, Wisconsin, United States, 53792
Contact: Toby C. Campbell    608-263-9823    tcc@medicine.wisc.edu   
Principal Investigator: Toby C. Campbell         
UW Health Oncology - 1 South Park Recruiting
Madison, Wisconsin, United States, 53715
Contact: Robert B. Hegeman    608-287-2552    robert.hegeman@uwmf.wisc.edu   
Principal Investigator: Robert B. Hegeman         
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Toby Campbell University of Wisconsin, Madison
  More Information

No publications provided

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01999881     History of Changes
Other Study ID Numbers: UW13034, NCI-2013-02185, 2013-0752, UW13034, P30CA014520
Study First Received: November 25, 2013
Last Updated: March 18, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Carcinoma, Non-Small-Cell Lung
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on October 23, 2014