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

SWOG Cancer Research Network

Status: Terminated

Conditions: Lung Cancer; Pulmonary Complications

Treatments: Other: supervised exercise program; Other: educational intervention

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT00090961

SWOG-S0229

U10CA012027 (U.S. NIH Grant/Contract)

CDR0000380928

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

2 participants in 2 patient groups

12-week exercise program + education

Experimental group

Description:

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.

Treatment:

Other: educational intervention

Other: supervised exercise program

Education

Other group

Description:

At the time of enrollment patients are provided educational materials focusing on breathing and energy conservation.

Treatment:

Other: educational intervention