Impacts of Exercise on Prognostic Biomarkers in Lung Cancer Patients

University of Wisconsin (UW)

Status: Completed

Conditions: Stage IIB Non-small Cell Lung Cancer; Stage IB Non-small Cell Lung Cancer; Stage IV Non-small Cell Lung Cancer; Stage IIA Non-small Cell Lung Cancer; Stage IIIA Non-small Cell Lung Cancer; Extensive Stage Small Cell Lung Cancer; Recurrent Non-small Cell Lung Cancer; Limited Stage Small Cell Lung Cancer; Stage IIIB Non-small Cell Lung Cancer; Stage IA Non-small Cell Lung Cancer; Healthy, no Evidence of Disease; Recurrent Small Cell Lung Cancer

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01999881

UW13034 (Other Identifier)

P30CA014520 (U.S. NIH Grant/Contract)

NCI-2013-02185 (Registry Identifier)

A534260 (Other Identifier)

SMPH\MEDICINE\HEM-ONC (Other Identifier)

2013-0752 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

21 participants in 2 patient groups

Arm A (aerobic and exercise training)

Experimental group

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.

Treatment:

Other: laboratory biomarker analysis

Procedure: quality-of-life assessment

Behavioral: exercise intervention

Arm II (usual care)

Active Comparator group

Description:

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

Treatment:

Other: laboratory biomarker analysis

Procedure: quality-of-life assessment

Procedure: standard follow-up care