Clinical trial NCT01999881: 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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2013-12-03
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change in biomarkers of inflammation
timeFrame: Baseline up to 8 weeks
measure: Change in oxidative damage as indicated by serum 8-hydroxydeoxyguanosine (8-oh-dG)
timeFrame: Baseline up to 8 weeks
measure: Change in time to walk 400 m
timeFrame: Baseline up to 8 weeks
measure: Change in physical well-being scores on the Functional Assessment of Cancer Therapy-Lung (FACT-L)
timeFrame: Baseline up to 8 weeks
measure: Change in functional well-being scores on the FACT-L
timeFrame: Baseline up to 8 weeks
Secondary outcomes:
measure: Change in stress scores on the SF-36
timeFrame: Baseline up to 8 weeks
measure: Change in quality-of-life scores on the SF-36
timeFrame: Baseline up to 8 weeks
Other outcomes:
Locations:
city: Madison
country: United States
facility: UW Health Oncology - 1 South Park
state: Wisconsin
city: Madison
country: United States
facility: University of Wisconsin, Madison
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Toby Campbell
role: PRINCIPAL_INVESTIGATOR
References: