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OpenTrials
Completed

NCT Number: NCT01999881

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.

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Key information

Conditions

Extensive Stage Small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Healthy, no Evidence of Disease Limited Stage Small Cell Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Recurrent Non-small Cell Lung Cancer Recurrent Small Cell Lung Cancer Respiratory Tract Diseases Respiratory Tract Neoplasms Small Cell Lung Carcinoma 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 Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise Intervention

Behavioral

Receive aerobic and exercise intervention

standard follow-up care

Procedure

Receive usual care

quality-of-life assessment

Procedure

Ancillary studies

Other names: quality of life assessment

laboratory biomarker analysis

Other

Correlative studies

Primary outcomes

  1. Change in biomarkers of inflammation

    Time frame: 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.

  2. Change in oxidative damage as indicated by serum 8-hydroxydeoxyguanosine (8-oh-dG)

    Time frame: 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.

  3. Change in time to walk 400 m

    Time frame: 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.

  4. Change in physical well-being scores on the Functional Assessment of Cancer Therapy-Lung (FACT-L)

    Time frame: 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.

  5. Change in functional well-being scores on the FACT-L

    Time frame: 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 outcomes

  1. Change in stress scores on the SF-36

    Time frame: 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.

  2. Change in quality-of-life scores on the SF-36

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Dec 3, 2013
Registry last updated
Nov 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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