Lung Cancer Clinical Trial
Official title:
A Randomized Trial Assessing the Effects of Exercise on Patients With Locally Advanced Lung Cancer Undergoing Curative Intent Combined Modality Therapy
Verified date | October 2012 |
Source | Southwest Oncology Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
RATIONALE: Pulmonary rehabilitation education and exercise training may improve physical
function and quality of life in patients who are receiving treatment for lung cancer.
PURPOSE: This randomized clinical trial is studying pulmonary rehabilitation education and
exercise training to see how well they work compared to exercise training alone in improving
physical function and quality of life in patients who are undergoing chemotherapy and
radiation therapy for locally advanced lung cancer.
Status | Terminated |
Enrollment | 2 |
Est. completion date | October 2008 |
Est. primary completion date | October 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed single, primary bronchogenic lung cancer - Inoperable, locally advanced disease (unresectable stage IIIA OR stage IIIB disease) - The following histologies are eligible: - Adenocarcinoma - Large cell carcinoma - Squamous cell carcinoma - Non-lobar and non-diffuse bronchoalveolar carcinoma - Small cell lung cancer - Must have received chemotherapy (platinum based) and radiotherapy for locally advanced unresectable lung cancer - Must have achieved a complete response, partial response, or stable disease after treatment PATIENT CHARACTERISTICS: Age - Not specified Performance status - Zubrod 0-2 Life expectancy - Not specified Hematopoietic - Not specified Hepatic - Not specified Renal - Not specified Cardiovascular - No acute EKG changes, arrhythmia, or other cardiac abnormality that would preclude study participation - No uncontrolled cardiac disease - No recent myocardial infarction Pulmonary - Any FEV_1 level by pulmonary function testing Other - Willing to participate in 12-week long exercise program - Chemotherapy-induced neuropathy = grade 2 - No uncontrolled diabetes mellitus - No other medical condition that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - See Disease Characteristics Endocrine therapy - Not specified Radiotherapy - See Disease Characteristics Surgery - Not specified |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
United States | St. Joseph Cancer Center | Bellingham | Washington |
United States | Billings Clinic - Downtown | Billings | Montana |
United States | CCOP - Montana Cancer Consortium | Billings | Montana |
United States | Hematology-Oncology Centers of the Northern Rockies - Billings | Billings | Montana |
United States | Northern Rockies Radiation Oncology Center | Billings | Montana |
United States | St. Vincent Healthcare Cancer Care Services | Billings | Montana |
United States | Bozeman Deaconess Cancer Center | Bozeman | Montana |
United States | Olympic Hematology and Oncology | Bremerton | Washington |
United States | St. James Healthcare Cancer Care | Butte | Montana |
United States | Cancer Center of Kansas, PA - Chanute | Chanute | Kansas |
United States | Decatur Memorial Hospital Cancer Care Institute | Decatur | Illinois |
United States | Barbara Ann Karmanos Cancer Institute | Detroit | Michigan |
United States | Cancer Center of Kansas, PA - Dodge City | Dodge City | Kansas |
United States | Cancer Center of Kansas, PA - El Dorado | El Dorado | Kansas |
United States | Poudre Valley Hospital | Fort Collins | Colorado |
United States | Wayne Memorial Hospital, Incorporated | Goldsboro | North Carolina |
United States | Big Sky Oncology | Great Falls | Montana |
United States | Great Falls Clinic - Main Facility | Great Falls | Montana |
United States | Sletten Cancer Institute at Benefis Healthcare | Great Falls | Montana |
United States | Northern Montana Hospital | Havre | Montana |
United States | St. Peter's Hospital | Helena | Montana |
United States | Cancer Center of Kansas-Independence | Independence | Kansas |
United States | Glacier Oncology, PLLC | Kalispell | Montana |
United States | Kalispell Medical Oncology at KRMC | Kalispell | Montana |
United States | Kalispell Regional Medical Center | Kalispell | Montana |
United States | Columbia Basin Hematology | Kennewick | Washington |
United States | Cancer Center of Kansas, PA - Kingman | Kingman | Kansas |
United States | Southwest Medical Center | Liberal | Kansas |
United States | Cardinal Bernardin Cancer Center at Loyola University Medical Center | Maywood | Illinois |
United States | Community Medical Center | Missoula | Montana |
United States | Guardian Oncology and Center for Wellness | Missoula | Montana |
United States | Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | Missoula | Montana |
United States | Montana Cancer Specialists at Montana Cancer Center | Missoula | Montana |
United States | Cancer Center of Kansas, PA - Newton | Newton | Kansas |
United States | Cancer Center of Kansas, PA - Parsons | Parsons | Kansas |
United States | Regional Cancer Center at Singing River Hospital | Pascagoula | Mississippi |
United States | Cancer Center of Kansas, PA - Pratt | Pratt | Kansas |
United States | Cancer Center of Kansas, PA - Salina | Salina | Kansas |
United States | Tammy Walker Cancer Center at Salina Regional Health Center | Salina | Kansas |
United States | Fred Hutchinson Cancer Research Center | Seattle | Washington |
United States | Group Health Central Hospital | Seattle | Washington |
United States | Harborview Medical Center | Seattle | Washington |
United States | Minor and James Medical, PLLC | Seattle | Washington |
United States | Polyclinic First Hill | Seattle | Washington |
United States | Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | Seattle | Washington |
United States | University Cancer Center at University of Washington Medical Center | Seattle | Washington |
United States | Welch Cancer Center at Sheridan Memorial Hospital | Sheridan | Wyoming |
United States | Cancer Care Northwest - Spokane South | Spokane | Washington |
United States | CCOP - Cancer Research for the Ozarks | Springfield | Missouri |
United States | Hulston Cancer Center at Cox Medical Center South | Springfield | Missouri |
United States | Regional Cancer Center at Memorial Medical Center | Springfield | Illinois |
United States | St. John's Regional Health Center | Springfield | Missouri |
United States | Cancer Center of Kansas, PA - Wellington | Wellington | Kansas |
United States | Associates in Womens Health, PA - North Review | Wichita | Kansas |
United States | Cancer Center of Kansas, PA - Medical Arts Tower | Wichita | Kansas |
United States | Cancer Center of Kansas, PA - Wichita | Wichita | Kansas |
United States | CCOP - Wichita | Wichita | Kansas |
United States | Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita | Kansas |
United States | Cancer Center of Kansas, PA - Winfield | Winfield | Kansas |
Lead Sponsor | Collaborator |
---|---|
Southwest Oncology Group | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Exercise tolerance | comparison between the control and intervention arms in the percent change in the 6-minute walk distance between baseline and 6 months. | Baseline and at 6 months | No |
Secondary | Health-related quality of life | The difference in total score between pre-study and 6 months for the FACT-L Quality of Life measure. | Baseline and at 6 months. | No |
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