Stage IV Non-small Cell Lung Cancer Clinical Trial
Official title:
Impacts of Exercise on Prognostic Biomarkers in Lung Cancer Patients
Verified date | February 2016 |
Source | University of Wisconsin, Madison |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 21 |
Est. completion date | February 2016 |
Est. primary completion date | July 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Wisconsin, Madison | Madison | Wisconsin |
United States | UW Health Oncology - 1 South Park | Madison | Wisconsin |
Lead Sponsor | Collaborator |
---|---|
University of Wisconsin, Madison | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Baseline up to 8 weeks | |
Primary | Change in oxidative damage as indicated by serum 8-hydroxydeoxyguanosine (8-oh-dG) | 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 | |
Primary | Change in time to walk 400 m | 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 | |
Primary | Change in physical well-being scores on the Functional Assessment of Cancer Therapy-Lung (FACT-L) | 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 | |
Primary | Change in functional well-being scores on the FACT-L | 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 | Change in stress scores on the SF-36 | 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 | Change in quality-of-life scores on the SF-36 | 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01664754 -
Exemestane, Pemetrexed Disodium, and Carboplatin in Treating Post-Menopausal Women With Stage IV Non-Small Cell Lung Cancer
|
Phase 1 | |
Completed |
NCT02451930 -
A Study of the Combination of Necitumumab (LY3012211) and Pembrolizumab (MK3475) in Participants With NSCLC
|
Phase 1 | |
Withdrawn |
NCT02106559 -
Photodynamic Therapy During Surgery in Treating Patients With Pleural Malignancy
|
N/A | |
Completed |
NCT02364609 -
Pembrolizumab and Afatinib in Patients With Non-small Cell Lung Cancer With Resistance to Erlotinib
|
Phase 1 | |
Terminated |
NCT02495896 -
Recombinant EphB4-HSA Fusion Protein With Standard Chemotherapy Regimens in Treating Patients With Advanced or Metastatic Solid Tumors
|
Phase 1 | |
Completed |
NCT01935336 -
Study of Ponatinib in Patients With Lung Cancer Preselected Using Different Candidate Predictive Biomarkers
|
Phase 2 | |
Withdrawn |
NCT01971489 -
Buparlisib, Gemcitabine Hydrochloride, and Cisplatin in Treating Patients With Advanced Solid Tumors
|
Phase 1 | |
Completed |
NCT01839955 -
Erlotinib Hydrochloride and Quinacrine Dihydrochloride in Stage IIIB-IV Non-Small Cell Lung Cancer
|
Phase 1 | |
Terminated |
NCT01193868 -
RO4929097 in Treating Patients With Advanced Non-Small Cell Lung Cancer Who Have Recently Completed Treatment With Front-Line Chemotherapy
|
Phase 2 | |
Completed |
NCT00986674 -
Carboplatin and Paclitaxel Combined With Cetuximab and/or IMC-A12 in Patients With Advanced Non-Small Cell Lung Cancer
|
Phase 2 | |
Completed |
NCT00963807 -
Trial Comparing the Use of FLT PET to Standard CT to Assess Treatment Response of Neoadjuvant Docetaxel and Cisplatin in Stage IB-IIIA Resectable NSCLC
|
Phase 2 | |
Completed |
NCT00087412 -
S0341: Erlotinib in Treating Patients With Advanced Primary Non-Small Cell Lung Cancer
|
Phase 2 | |
Completed |
NCT00085280 -
Erlotinib in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer
|
N/A | |
Completed |
NCT00052338 -
Bortezomib Plus Gemcitabine and Carboplatin in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer
|
Phase 1 | |
Completed |
NCT00006929 -
Suramin, Paclitaxel, and Carboplatin in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer
|
Phase 2 | |
Completed |
NCT02879994 -
Pembrolizumab in Treating Patients With EGFR Mutant, Tyrosine Kinase Inhibitor Naive Advanced Non-Small Cell Lung Cancer
|
Phase 2 | |
Completed |
NCT03305380 -
Radiomics to Identify Patients at Risk for Developing Pneumonitis, Differentiate Immune Checkpoint Inhibitor-induced Pneumonitis From Other Lung Inflammation and Distinguish Tumour Pseudo-progression From Real Tumour Growth
|
||
Completed |
NCT02728596 -
S1415CD, Trial Assessing CSF Prescribing Effectiveness and Risk (TrACER)
|
N/A | |
Completed |
NCT02858869 -
Pembrolizumab and Stereotactic Radiosurgery for Melanoma or Non-Small Cell Lung Cancer Brain Metastases
|
Phase 1 | |
Completed |
NCT02897375 -
Palbociclib With Cisplatin or Carboplatin in Advanced Solid Tumors
|
Phase 1 |