Ignite Creation Date:
2024-05-05 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00090961
Status:
TERMINATED
Last Update Posted:
2012-11-01
First Post:
2004-09-07
Brief Title:
S0229 Pulmonary Rehabilitation Education wwo Exercise Training in Improving Physical Function in Patients Who Are Undergoing Chemo RT for Locally Advanced Lung Cancer
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
A Randomized Trial Assessing the Effects of Exercise on Patients With Locally Advanced Lung Cancer Undergoing Curative Intent Combined Modality Therapy
Status:
TERMINATED
Status Verified Date:
2012-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Closed early due to poor accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
OBJECTIVES
Compare improvement in physiologic function in terms of exercise tolerance in patients with inoperable locally advanced lung cancer undergoing chemoradiotherapy and randomized to pulmonary rehabilitation comprising education with vs without supervised exercise training
Compare the health-related quality of life in terms of multidimensional functioning and patient perception of respiratory difficulties in patients undergoing these pulmonary rehabilitation interventions
OUTLINE This is a randomized multicenter study Patients are stratified according to Zubrod performance status 0-1 vs 2 FEV_1 70 of predicted vs 70 of predicted and smoking status never smoked or former smoker vs current smoker Approximately 20 weeks into treatment on SWOG-S0023 patients are randomized to 1 of 2 intervention arms
NOTE Never smoked is defined as 100 cigarettes in a lifetime and former smoker is defined as no smoking for 1 year
Arm I Patients participate in a supervised structured exercise program ie walking on a treadmill OR using a stationary exercise bicycle 3 times a week for 12 weeks Patients also receive educational materials on how to improve breathing and conserve energy
Arm II Patients receive educational materials as in arm I In both arms patients undergo exercise testing using 6-minute walks to measure exercise tolerance at initial evaluation after randomization but prior to intervention 12 weeks and then at 6 and 9 months
In both arms intervention continues in the absence of disease progression or the development of other medical conditions that would preclude study participation
Quality of life is assessed at baseline 12 weeks and then at 6 and 9 months
PROJECTED ACCRUAL A total of 164 patients 82 per treatment arm will be accrued for this study
Compare improvement in physiologic function in terms of exercise tolerance in patients with inoperable locally advanced lung cancer undergoing chemoradiotherapy and randomized to pulmonary rehabilitation comprising education with vs without supervised exercise training
Compare the health-related quality of life in terms of multidimensional functioning and patient perception of respiratory difficulties in patients undergoing these pulmonary rehabilitation interventions
OUTLINE This is a randomized multicenter study Patients are stratified according to Zubrod performance status 0-1 vs 2 FEV_1 70 of predicted vs 70 of predicted and smoking status never smoked or former smoker vs current smoker Approximately 20 weeks into treatment on SWOG-S0023 patients are randomized to 1 of 2 intervention arms
NOTE Never smoked is defined as 100 cigarettes in a lifetime and former smoker is defined as no smoking for 1 year
Arm I Patients participate in a supervised structured exercise program ie walking on a treadmill OR using a stationary exercise bicycle 3 times a week for 12 weeks Patients also receive educational materials on how to improve breathing and conserve energy
Arm II Patients receive educational materials as in arm I In both arms patients undergo exercise testing using 6-minute walks to measure exercise tolerance at initial evaluation after randomization but prior to intervention 12 weeks and then at 6 and 9 months
In both arms intervention continues in the absence of disease progression or the development of other medical conditions that would preclude study participation
Quality of life is assessed at baseline 12 weeks and then at 6 and 9 months
PROJECTED ACCRUAL A total of 164 patients 82 per treatment arm will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U10CA012027 | NIH | None | None |
| SWOG-S0229 | US NIH GrantContract | None | httpsreporternihgovquickSearchU10CA012027 |