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
  Purpose

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 Intervention
Lung Cancer
Pulmonary Complications
Other: educational intervention
Other: supervised exercise program

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 2
Study Start Date: September 2004
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other: educational intervention Other: supervised exercise program
Education
At the time of enrollment patients are provided educational materials focusing on breathing and energy conservation.
Other: educational intervention

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00090961

  Show 60 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
Investigators
Study Chair: Antoinette J. Wozniak, MD Barbara Ann Karmanos Cancer Institute
  More Information

No publications provided

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00090961     History of Changes
Other Study ID Numbers: CDR0000380928, U10CA012027, SWOG-S0229
Study First Received: September 7, 2004
Last Updated: October 31, 2012
Health Authority: United States: Federal Government

Keywords provided by Southwest Oncology Group:
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

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 23, 2014