Lung CancerNCT00090961
S0229, Pulmonary Rehabilitation Education w/wo Exercise Training in Improving Physical Function in Patients Who Are Undergoing Chemo & RT for Locally Advanced Lung Cancer
A study testing educational intervention and supervised exercise program in people with Lung Cancer and Pulmonary Complications, run by SWOG Cancer Research Network at 60 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lung Cancer, Pulmonary Complications
- What is being tested?
- educational intervention and supervised exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 60 sitesUnited States
- Study dates
- Sep 2004to Oct 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Trial locations and contacts
60 sites in 1 country.
60 sites in 1 country
United States60 sites
St. Joseph Cancer Center
Bellingham, Washington, 98225
CCOP - Montana Cancer Consortium
Billings, Montana, 59101
Hematology-Oncology Centers of the Northern Rockies - Billings
Billings, Montana, 59101
Northern Rockies Radiation Oncology Center
Billings, Montana, 59101
St. Vincent Healthcare Cancer Care Services
Billings, Montana, 59101
Billings Clinic - Downtown
Billings, Montana, 59107-7000
Bozeman Deaconess Cancer Center
Bozeman, Montana, 59715
Olympic Hematology and Oncology
Bremerton, Washington, 98310
St. James Healthcare Cancer Care
Butte, Montana, 59701
Cancer Center of Kansas, PA - Chanute
Chanute, Kansas, 66720
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, 62526
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379
Cancer Center of Kansas, PA - Dodge City
Dodge City, Kansas, 67801
Cancer Center of Kansas, PA - El Dorado
El Dorado, Kansas, 67042
Poudre Valley Hospital
Fort Collins, Colorado, 80524
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, 27534
Big Sky Oncology
Great Falls, Montana, 59405-5309
Great Falls Clinic - Main Facility
Great Falls, Montana, 59405
Sletten Cancer Institute at Benefis Healthcare
Great Falls, Montana, 59405
Study site
Great Falls, Montana, 59405
Northern Montana Hospital
Havre, Montana, 59501
St. Peter's Hospital
Helena, Montana, 59601
Cancer Center of Kansas-Independence
Independence, Kansas, 67301
Glacier Oncology, PLLC
Kalispell, Montana, 59901
Kalispell Medical Oncology at KRMC
Kalispell, Montana, 59901
Kalispell Regional Medical Center
Kalispell, Montana, 59901
Columbia Basin Hematology
Kennewick, Washington, 99336
Cancer Center of Kansas, PA - Kingman
Kingman, Kansas, 67068
Southwest Medical Center
Liberal, Kansas, 67901
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, 60153
Community Medical Center
Missoula, Montana, 59801
Guardian Oncology and Center for Wellness
Missoula, Montana, 59804
Montana Cancer Specialists at Montana Cancer Center
Missoula, Montana, 59807-7877
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Missoula, Montana, 59807
Cancer Center of Kansas, PA - Newton
Newton, Kansas, 67114
Cancer Center of Kansas, PA - Parsons
Parsons, Kansas, 67357
Regional Cancer Center at Singing River Hospital
Pascagoula, Mississippi, 39581
Cancer Center of Kansas, PA - Pratt
Pratt, Kansas, 67124
Cancer Center of Kansas, PA - Salina
Salina, Kansas, 67042
Tammy Walker Cancer Center at Salina Regional Health Center
Salina, Kansas, 67401
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98104
Harborview Medical Center
Seattle, Washington, 98104
Minor and James Medical, PLLC
Seattle, Washington, 98104
Group Health Central Hospital
Seattle, Washington, 98112
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Seattle, Washington, 98122-4307
Polyclinic First Hill
Seattle, Washington, 98122
University Cancer Center at University of Washington Medical Center
Seattle, Washington, 98195-6043
Welch Cancer Center at Sheridan Memorial Hospital
Sheridan, Wyoming, 82801
Cancer Care Northwest - Spokane South
Spokane, Washington, 99202
Regional Cancer Center at Memorial Medical Center
Springfield, Illinois, 62781-0001
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, 65802
St. John's Regional Health Center
Springfield, Missouri, 65804
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, 65807
Cancer Center of Kansas, PA - Wellington
Wellington, Kansas, 67152
Associates in Womens Health, PA - North Review
Wichita, Kansas, 67208
Cancer Center of Kansas, PA - Medical Arts Tower
Wichita, Kansas, 67208
Cancer Center of Kansas, PA - Wichita
Wichita, Kansas, 67214
CCOP - Wichita
Wichita, Kansas, 67214
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, 67214
Cancer Center of Kansas, PA - Winfield
Winfield, Kansas, 67156
About this study
Official title: A Randomized Trial Assessing the Effects of Exercise on Patients With Locally Advanced Lung Cancer Undergoing Curative Intent Combined Modality Therapy
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.
Read the 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.
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.
- Conditions
- Lung Cancer, Pulmonary Complications
- Being tested
- educational intervention, supervised exercise program
- Keywords
- 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
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma of Lung, Adenocarcinoma, Bronchiolo-Alveolar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
educational interventionOther
supervised exercise programOther
| Study group | Role | What they receive |
|---|---|---|
| 12-week exercise program + education | Experimental | 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. Receives: Other: educational intervention; Other: supervised exercise program |
| Education | Other | At the time of enrollment patients are provided educational materials focusing on breathing and energy conservation. Receives: Other: educational intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise tolerance
comparison between the control and intervention arms in the percent change in the 6-minute walk distance between baseline and 6 months.
Measured: Baseline and at 6 months
Secondary outcomes (1)
Health-related quality of life
The difference in total score between pre-study and 6 months for the FACT-L Quality of Life measure.
Measured: Baseline and at 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2004 (estimated)
- Study startSep 2004
- Primary completionOct 2008
- Study completionOct 2008
Why it stopped: Closed early due to poor accrual.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by SWOG Cancer Research NetworkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- SWOG Cancer Research Network
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Antoinette J. Wozniak, MD, Study chair, Barbara Ann Karmanos Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00090961
- Sponsor's protocol ID
- CDR0000380928
- Other IDs
- U10CA012027, SWOG-S0229
- Status last verified
- Oct 2012
- First submitted
- 7 Sep 2004
- Last updated
- 1 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial Assessing the Effects of Exercise on Patients With Locally Advanced Lung Cancer Undergoing Curative Intent Combined Modality Therapy
- ClinicalTrials.gov ID
- NCT00090961
- Acronym / sponsor ID
- CDR0000380928
- Conditions
- Lung Cancer, Pulmonary Complications
- Keywords
- 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
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Closed early due to poor accrual.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- SWOG Cancer Research NetworkResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 2004
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 8 Sep 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 12-week exercise program + education | Experimental | Other: educational intervention, Other: supervised exercise programA 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. |
| Education | Other | Other: educational interventionAt the time of enrollment patients are provided educational materials focusing on breathing and energy conservation. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| educational intervention | Other | 12-week exercise program + education, Education |
| supervised exercise program | Other | 12-week exercise program + education |
Primary outcome
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.
1 secondary outcome
Health-related quality of life
Time frame: Baseline and at 6 months.
Results and safety
The study was stopped early (reason given: Closed early due to poor accrual.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antoinette J. Wozniak, MD study chair
Barbara Ann Karmanos Cancer Institute
60 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing educational intervention and supervised exercise program in people with Lung Cancer and Pulmonary Complications, run by SWOG Cancer Research Network at 60 sites in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 60 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Closed early due to poor accrual.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise tolerance (time frame: Baseline and at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2012.