Impacts of Exercise on Prognostic Biomarkers in Lung Cancer Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2016-02-29

Brief Summary

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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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Detailed Description

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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.

Conditions

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

exercise intervention

Intervention Type BEHAVIORAL

Receive aerobic and exercise intervention

quality-of-life assessment

Intervention Type PROCEDURE

Ancillary studies

laboratory biomarker analysis

Intervention Type OTHER

Correlative studies

Arm II (usual care)

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

Group Type ACTIVE_COMPARATOR

standard follow-up care

Intervention Type PROCEDURE

Receive usual care

quality-of-life assessment

Intervention Type PROCEDURE

Ancillary studies

laboratory biomarker analysis

Intervention Type OTHER

Correlative studies

Interventions

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exercise intervention

Receive aerobic and exercise intervention

Intervention Type BEHAVIORAL

standard follow-up care

Receive usual care

Intervention Type PROCEDURE

quality-of-life assessment

Ancillary studies

Intervention Type PROCEDURE

laboratory biomarker analysis

Correlative studies

Intervention Type OTHER

Other Intervention Names

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quality of life assessment

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes