S0229, Pulmonary Rehabilitation Education w/wo Exercise Training in Improving Physical Function in Patients Who Are Undergoing Chemo & RT for Locally Advanced Lung Cancer
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| ClinicalTrials.gov Identifier: NCT00090961 |
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Recruitment Status :
Terminated
(Closed early due to poor accrual.)
First Posted : September 8, 2004
Last Update Posted : November 1, 2012
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Lung Cancer Pulmonary Complications | Other: educational intervention Other: supervised exercise program | Not Applicable |
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.
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 2 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Official Title: | A Randomized Trial Assessing the Effects of Exercise on Patients With Locally Advanced Lung Cancer Undergoing Curative Intent Combined Modality Therapy |
| Study Start Date : | September 2004 |
| Actual Primary Completion Date : | October 2008 |
| Actual Study Completion Date : | October 2008 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: 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.
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Other: educational intervention Other: supervised exercise program |
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Education
At the time of enrollment patients are provided educational materials focusing on breathing and energy conservation.
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Other: educational intervention |
- 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.
- Health-related quality of life [ Time Frame: Baseline and at 6 months. ]The difference in total score between pre-study and 6 months for the FACT-L Quality of Life measure.
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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Histologically or cytologically confirmed single, primary bronchogenic lung cancer
- Inoperable, locally advanced disease (unresectable stage IIIA OR stage IIIB disease)
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The following histologies are eligible:
- Adenocarcinoma
- Large cell carcinoma
- Squamous cell carcinoma
- Non-lobar and non-diffuse bronchoalveolar carcinoma
- Small cell lung cancer
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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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00090961
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| Study Chair: | Antoinette J. Wozniak, MD | Barbara Ann Karmanos Cancer Institute |
| Responsible Party: | Southwest Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00090961 |
| Other Study ID Numbers: |
CDR0000380928 U10CA012027 ( U.S. NIH Grant/Contract ) SWOG-S0229 |
| First Posted: | September 8, 2004 Key Record Dates |
| Last Update Posted: | November 1, 2012 |
| Last Verified: | October 2012 |
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pulmonary complications stage IIIA non-small cell lung cancer stage IIIB non-small cell lung cancer squamous cell lung cancer |
large cell lung cancer adenocarcinoma of the lung bronchoalveolar cell lung cancer limited stage small cell lung cancer |
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Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Neoplasms Lung Diseases Respiratory Tract Diseases |