A Randomized Trial Assessing the Effects of Exercise on Patients With Locally Advanced Lung Cancer Undergoing Curative Intent Combined Modality Therapy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- SWOG Cancer Research Network
- Enrollment
- 2
- Locations
- 60
- Primary Endpoint
- Exercise tolerance
Study Overview
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.
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 (i.e., 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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:
- •Not specified
- •Performance status
- •Zubrod 0-2
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Not specified
- •Not specified
- •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
- •Any FEV_1 level by pulmonary function testing
- •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
- •Not specified
Exclusion Criteria
- Not provided
Arms & Interventions
12-week exercise program + education
A 12-week supervised exercise program consisting of 3 days a week on a stationary bike or treadmill. In addition, at the time of enrollment patients are provided educational materials focusing on breathing and energy conservation.
Intervention: educational intervention (Other)
12-week exercise program + education
A 12-week supervised exercise program consisting of 3 days a week on a stationary bike or treadmill. In addition, at the time of enrollment patients are provided educational materials focusing on breathing and energy conservation.
Intervention: supervised exercise program (Other)
Education
At the time of enrollment patients are provided educational materials focusing on breathing and energy conservation.
Intervention: educational intervention (Other)
Outcomes
Primary Outcomes
Exercise tolerance
Time Frame: Baseline and at 6 months
comparison between the control and intervention arms in the percent change in the 6-minute walk distance between baseline and 6 months.
Secondary Outcomes
- Health-related quality of life(Baseline and at 6 months.)