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Impacts of Exercise on Prognostic Biomarkers in Lung Cancer Patients

Primary Purpose

Extensive Stage Small Cell Lung Cancer, Healthy, no Evidence of Disease, Limited Stage Small Cell Lung Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
exercise intervention
standard follow-up care
quality-of-life assessment
laboratory biomarker analysis
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Extensive Stage Small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • UW Health Oncology - 1 South Park
  • University of Wisconsin, Madison

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm A (aerobic and exercise training)

Arm II (usual care)

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
November 25, 2013
Last Updated
November 14, 2019
Sponsor
University of Wisconsin, Madison
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01999881
Brief Title
Impacts of Exercise on Prognostic Biomarkers in Lung Cancer Patients
Official Title
Impacts of Exercise on Prognostic Biomarkers in Lung Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A (aerobic and exercise training)
Arm Type
Experimental
Arm Description
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 Title
Arm II (usual care)
Arm Type
Active Comparator
Arm Description
Patients and their support persons undergo the usual care over 8 weeks.
Intervention Type
Behavioral
Intervention Name(s)
exercise intervention
Intervention Description
Receive aerobic and exercise intervention
Intervention Type
Procedure
Intervention Name(s)
standard follow-up care
Intervention Description
Receive usual care
Intervention Type
Procedure
Intervention Name(s)
quality-of-life assessment
Other Intervention Name(s)
quality of life assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Change in biomarkers of inflammation
Description
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.
Time Frame
Baseline up to 8 weeks
Title
Change in oxidative damage as indicated by serum 8-hydroxydeoxyguanosine (8-oh-dG)
Description
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.
Time Frame
Baseline up to 8 weeks
Title
Change in time to walk 400 m
Description
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.
Time Frame
Baseline up to 8 weeks
Title
Change in physical well-being scores on the Functional Assessment of Cancer Therapy-Lung (FACT-L)
Description
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.
Time Frame
Baseline up to 8 weeks
Title
Change in functional well-being scores on the FACT-L
Description
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.
Time Frame
Baseline up to 8 weeks
Secondary Outcome Measure Information:
Title
Change in stress scores on the SF-36
Description
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.
Time Frame
Baseline up to 8 weeks
Title
Change in quality-of-life scores on the SF-36
Description
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.
Time Frame
Baseline up to 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Toby Campbell
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
UW Health Oncology - 1 South Park
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53715
Country
United States
Facility Name
University of Wisconsin, Madison
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States

12. IPD Sharing Statement

Links:
URL
https://cancer.wisc.edu/
Description
University of Wisconsin Carbone Cancer Center

Learn more about this trial

Impacts of Exercise on Prognostic Biomarkers in Lung Cancer Patients

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