S0229, Pulmonary Rehabilitation Education w/wo Exercise Training in Improving Physical Function in Patients Who Are Undergoing Chemo & RT for Locally Advanced Lung Cancer

This study has been terminated.
(Closed early due to poor accrual.)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00090961
First received: September 7, 2004
Last updated: October 31, 2012
Last verified: October 2012

September 7, 2004
October 31, 2012
September 2004
October 2008   (final data collection date for primary outcome measure)
Exercise tolerance [ Time Frame: Baseline and at 6 months ] [ Designated as safety issue: No ]
comparison between the control and intervention arms in the percent change in the 6-minute walk distance between baseline and 6 months.
Not Provided
Complete list of historical versions of study NCT00090961 on ClinicalTrials.gov Archive Site
Health-related quality of life [ Time Frame: Baseline and at 6 months. ] [ Designated as safety issue: No ]
The difference in total score between pre-study and 6 months for the FACT-L Quality of Life measure.
Not Provided
Not Provided
Not Provided
 
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 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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
  • Lung Cancer
  • Pulmonary Complications
  • Other: educational intervention
  • Other: supervised exercise program
  • 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.
    Interventions:
    • Other: educational intervention
    • Other: supervised exercise program
  • Education
    At the time of enrollment patients are provided educational materials focusing on breathing and energy conservation.
    Intervention: Other: educational intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
2
October 2008
October 2008   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00090961
CDR0000380928, U10CA012027, SWOG-S0229
No
Southwest Oncology Group
Southwest Oncology Group
National Cancer Institute (NCI)
Study Chair: Antoinette J. Wozniak, MD Barbara Ann Karmanos Cancer Institute
Southwest Oncology Group
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP