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A Randomized Trial Assessing the Effects of Exercise on Patients With Locally Advanced Lung Cancer Undergoing Curative Intent Combined Modality Therapy

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Lung Cancer, Pulmonary Complications

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Trial Information

A Randomized Trial Assessing the Effects of Exercise on Patients With Locally Advanced Lung Cancer Undergoing Curative Intent Combined Modality Therapy


- 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

- 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

Inclusion Criteria


- Histologically or cytologically confirmed single, primary bronchogenic lung cancer

- Inoperable, locally advanced disease (unresectable stage IIIA OR stage IIIB

- 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



- Not specified

Performance status

- Zubrod 0-2

Life expectancy

- Not specified


- Not specified


- Not specified


- Not specified


- No acute EKG changes, arrhythmia, or other cardiac abnormality that would preclude
study participation

- No uncontrolled cardiac disease

- No recent myocardial infarction


- Any FEV_1 level by pulmonary function testing


- 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


Biologic therapy

- Not specified


- See Disease Characteristics

Endocrine therapy

- Not specified


- See Disease Characteristics


- Not specified

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Outcome Measure:

Exercise tolerance

Outcome Description:

comparison between the control and intervention arms in the percent change in the 6-minute walk distance between baseline and 6 months.

Outcome Time Frame:

Baseline and at 6 months

Safety Issue:


Principal Investigator

Antoinette J. Wozniak, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Barbara Ann Karmanos Cancer Institute


United States: Federal Government

Study ID:




Start Date:

September 2004

Completion Date:

October 2008

Related Keywords:

  • Lung Cancer
  • Pulmonary Complications
  • 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
  • Lung Neoplasms



Fred Hutchinson Cancer Research Center Seattle, Washington  98109
Cardinal Bernardin Cancer Center at Loyola University Medical Center Maywood, Illinois  60153-5500
Barbara Ann Karmanos Cancer Institute Detroit, Michigan  48201
CCOP - Wichita Wichita, Kansas  67214-3882
CCOP - Cancer Research for the Ozarks Springfield, Missouri  65807
CCOP - Montana Cancer Consortium Billings, Montana  59101
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus Seattle, Washington  98104
Hulston Cancer Center at Cox Medical Center South Springfield, Missouri  65807
St. John's Regional Health Center Springfield, Missouri  65804
Via Christi Cancer Center at Via Christi Regional Medical Center Wichita, Kansas  67214
Southwest Medical Center Liberal, Kansas  67901
Northern Rockies Radiation Oncology Center Billings, Montana  59101
Hematology-Oncology Centers of the Northern Rockies - Billings Billings, Montana  59101
Big Sky Oncology Great Falls, Montana  59405
St. Peter's Hospital Helena, Montana  59601
Kalispell Regional Medical Center Kalispell, Montana  59901
Glacier Oncology, PLLC Kalispell, Montana  59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center Missoula, Montana  59802
Montana Cancer Specialists at Montana Cancer Center Missoula, Montana  59802
Community Medical Center Missoula, Montana  59801
Wayne Memorial Hospital, Incorporated Goldsboro, North Carolina  27534
Olympic Hematology and Oncology Bremerton, Washington  98310
University Cancer Center at University of Washington Medical Center Seattle, Washington  98195
Harborview Medical Center Seattle, Washington  98104
Group Health Central Hospital Seattle, Washington  98104
Cancer Care Northwest - Spokane South Spokane, Washington  99202
Decatur Memorial Hospital Cancer Care Institute Decatur, Illinois  62526
Poudre Valley Hospital Fort Collins, Colorado  80524
Cancer Center of Kansas, PA - Dodge City Dodge City, Kansas  67801
Minor and James Medical, PLLC Seattle, Washington  98104
Polyclinic First Hill Seattle, Washington  98122
Welch Cancer Center at Sheridan Memorial Hospital Sheridan, Wyoming  82801
Regional Cancer Center at Singing River Hospital Pascagoula, Mississippi  39581
Cancer Center of Kansas, PA - Chanute Chanute, Kansas  66720
Cancer Center of Kansas, PA - El Dorado El Dorado, Kansas  67042
Cancer Center of Kansas-Independence Independence, Kansas  67301
Cancer Center of Kansas, PA - Kingman Kingman, Kansas  67068
Cancer Center of Kansas, PA - Newton Newton, Kansas  67114
Cancer Center of Kansas, PA - Parsons Parsons, Kansas  67357
Cancer Center of Kansas, PA - Pratt Pratt, Kansas  67124
Tammy Walker Cancer Center at Salina Regional Health Center Salina, Kansas  67401
Cancer Center of Kansas, PA - Salina Salina, Kansas  67401
Cancer Center of Kansas, PA - Wellington Wellington, Kansas  67152
Cancer Center of Kansas, PA - Wichita Wichita, Kansas  67214
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 - Winfield Winfield, Kansas  67156
Billings Clinic - Downtown Billings, Montana  59107-7000
Bozeman Deaconess Cancer Center Bozeman, Montana  59715
St. James Healthcare Cancer Care Butte, Montana  59701
Great Falls Clinic - Main Facility Great Falls, Montana  59405
Sletten Cancer Institute at Benefis Healthcare Great Falls, Montana  59405
Northern Montana Hospital Havre, Montana  59501
Kalispell Medical Oncology at KRMC Kalispell, Montana  59901
St. Joseph Cancer Center Bellingham, Washington  98225
Columbia Basin Hematology Kennewick, Washington  99336
Regional Cancer Center at Memorial Medical Center Springfield, Illinois  62781-0001
Great Falls, Montana  59405
Guardian Oncology and Center for Wellness Missoula, Montana  59804
St. Vincent Healthcare Cancer Care Services Billings, Montana  59101