- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01999881
Impacts of Exercise on Prognostic Biomarkers in Lung Cancer Patients
Study Overview
Status
Conditions
- Stage IIIA Non-small Cell Lung Cancer
- Stage IIIB Non-small Cell Lung Cancer
- Extensive Stage Small Cell Lung Cancer
- Recurrent Small Cell Lung Cancer
- Recurrent Non-small Cell Lung Cancer
- Stage IV Non-small Cell Lung Cancer
- Healthy, no Evidence of Disease
- Limited Stage 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
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Wisconsin
-
Madison, Wisconsin, United States, 53715
- UW Health Oncology - 1 South Park
-
Madison, Wisconsin, United States, 53792
- University of Wisconsin, Madison
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
Correlative studies
Ancillary studies
Other Names:
Receive aerobic and exercise intervention
|
Active Comparator: Arm II (usual care)
Patients and their support persons undergo the usual care over 8 weeks.
|
Correlative studies
Ancillary studies
Other Names:
Receive usual care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline up to 8 weeks
|
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.
|
Baseline up to 8 weeks
|
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.
|
Baseline up to 8 weeks
|
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.
|
Baseline up to 8 weeks
|
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.
|
Baseline up to 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline up to 8 weeks
|
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.
|
Baseline up to 8 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Toby Campbell, University of Wisconsin, Madison
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UW13034 (Other Identifier: University of Wisconsin Carbone Cancer Center)
- P30CA014520 (U.S. NIH Grant/Contract)
- A534260 (Other Identifier: UW Madison)
- SMPH\MEDICINE\HEM-ONC (Other Identifier: UW Madison)
- 2013-0752 (Other Identifier: Institutional Review Board)
- NCI-2013-02185 (Registry Identifier: NCI Trial ID)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Stage IIIA Non-small Cell Lung Cancer
-
University of California, San FranciscoAstraZenecaActive, not recruitingStage IIIA Non-Small Cell Lung Cancer | Stage I Non-Small Cell Lung Cancer | Stage IA Non-Small Cell Lung Cancer | Stage IB Non-Small Cell Lung Cancer | Stage II Non-Small Cell Lung Cancer | Stage IIA Non-Small Cell Lung Cancer | Stage IIB Non-Small Cell Lung CancerUnited States
-
National Cancer Institute (NCI)Not yet recruitingStage IIIA Non-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 CancerCanada
-
National Cancer Institute (NCI)TerminatedStage IIIA Non-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 CancerUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)CompletedStage IIA Rectal Cancer | Stage IIB Rectal Cancer | Stage IIC Rectal Cancer | Stage IIIA Rectal Cancer | Stage IIIB Rectal Cancer | Stage IIIC Rectal Cancer | Stage IIIA Non-small Cell Lung Cancer | Stage IIIB Non-small Cell Lung Cancer | Stage IIIA Colon Cancer | Stage IIIB Colon Cancer | Stage IIIC Colon... and other conditionsUnited States
-
Peking UniversityMerck Sharp & Dohme LLC; Cancer Institute and Hospital, Chinese Academy of... and other collaboratorsRecruitingStage IIIA Non-small Cell Lung Cancer | Stage IIA Non-small Cell Lung Cancer | Stage IIB Non-small Cell Lung Cancer | Stage IIIB(N2) Non-small Cell Lung CancerChina
-
Washington University School of MedicineActive, not recruitingStage IIIA Non-small Cell Lung Cancer | Stage IIIB Non-small Cell Lung Cancer | Stage IIB Non-Small Cell Lung Cancer | Stage IIIC Non-Small Cell Lung CancerUnited States
-
H. Lee Moffitt Cancer Center and Research InstituteNestle Health ScienceWithdrawnNSCLC | Non Small Cell Lung Cancer | Non-small Cell Lung Cancer | NSCLC Stage IIIB | Non-small Cell Lung Cancer Stage IIIB | NSCLC, Stage IIIA | Non-small Cell Lung Cancer Stage ⅢAUnited States
-
Karen KellyBristol-Myers Squibb; National Cancer Institute (NCI); TransgeneCompletedStage IIIA Non-Small Cell Lung Cancer | Stage IIIB Non-Small Cell Lung Cancer | Recurrent Non-Small Cell Lung Carcinoma | Stage IV Non-Small Cell Lung Cancer | Stage I Non-Small Cell Lung Cancer | Stage II Non-Small Cell Lung CancerUnited States
-
National Cancer Institute (NCI)RecruitingStage IIA Lung Cancer AJCC v8 | Stage IIB Lung Cancer AJCC v8 | Stage IIIA Lung Cancer AJCC v8 | Stage IIIB Lung Cancer AJCC v8 | Stage IB Lung Non-Small Cell Carcinoma AJCC v7 | Stage II Lung Non-Small Cell Cancer AJCC v7 | Stage IIIA Lung Non-Small Cell Cancer AJCC v7United States, Guam, Puerto Rico
-
Emory UniversityWashington University Siteman Cancer CenterActive, not recruitingStage IIIA Non-small Cell Lung Cancer | Stage IIIB Non-small Cell Lung Cancer | Stage IIA Non-small Cell Lung Cancer | Stage IIB Non-small Cell Lung CancerUnited States
Clinical Trials on laboratory biomarker analysis
-
ECOG-ACRIN Cancer Research GroupNational Cancer Institute (NCI)CompletedProstate Cancer
-
Children's Oncology GroupNational Cancer Institute (NCI)Completed
-
National Cancer Institute (NCI)Recruiting
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)Not yet recruitingLynch Syndrome | Recurrent Uterine Corpus Carcinoma | Stage I Uterine Corpus Cancer | Stage II Uterine Corpus Cancer | Stage III Uterine Corpus Cancer | Stage IV Uterine Corpus CancerUnited States
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)Not yet recruitingRecurrent Uterine Corpus Carcinoma | Stage III Uterine Corpus Cancer | Stage IV Uterine Corpus CancerUnited States
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)RecruitingStage IIIA Ovarian Cancer | Stage IIIB Ovarian Cancer | Stage IIIC Ovarian Cancer | Stage IV Ovarian CancerUnited States
-
National Cancer Institute (NCI)Active, not recruitingMalignant NeoplasmUnited States
-
Ohio State University Comprehensive Cancer CenterActive, not recruitingLung Cancer | Radiation Toxicity | Adult Brain TumorUnited States
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedRecurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor | Metastatic Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor | Localized Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor | Askin TumorUnited States, Canada, Puerto Rico, Australia, New Zealand, Switzerland
-
Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)Completed