Impacts of Exercise on Prognostic Biomarkers in Lung Cancer Patients

N/ACompletedNCT01999881

University of Wisconsin, Madison21 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Extensive Stage Small Cell Lung Cancer

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.