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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


N/A
N/A
N/A
Not Enrolling
Both
Lung Cancer, Pulmonary Complications

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

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:

No

Principal Investigator

Antoinette J. Wozniak, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Barbara Ann Karmanos Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000380928

NCT ID:

NCT00090961

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

Name

Location

Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
Cardinal Bernardin Cancer Center at Loyola University Medical CenterMaywood, Illinois  60153-5500
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
CCOP - WichitaWichita, Kansas  67214-3882
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
Swedish Cancer Institute at Swedish Medical Center - First Hill CampusSeattle, Washington  98104
Hulston Cancer Center at Cox Medical Center SouthSpringfield, Missouri  65807
St. John's Regional Health CenterSpringfield, Missouri  65804
Via Christi Cancer Center at Via Christi Regional Medical CenterWichita, Kansas  67214
Southwest Medical CenterLiberal, Kansas  67901
Northern Rockies Radiation Oncology CenterBillings, Montana  59101
Hematology-Oncology Centers of the Northern Rockies - BillingsBillings, Montana  59101
Big Sky OncologyGreat Falls, Montana  59405
St. Peter's HospitalHelena, Montana  59601
Kalispell Regional Medical CenterKalispell, Montana  59901
Glacier Oncology, PLLCKalispell, Montana  59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences CenterMissoula, Montana  59802
Montana Cancer Specialists at Montana Cancer CenterMissoula, Montana  59802
Community Medical CenterMissoula, Montana  59801
Wayne Memorial Hospital, IncorporatedGoldsboro, North Carolina  27534
Olympic Hematology and OncologyBremerton, Washington  98310
University Cancer Center at University of Washington Medical CenterSeattle, Washington  98195
Harborview Medical CenterSeattle, Washington  98104
Group Health Central HospitalSeattle, Washington  98104
Cancer Care Northwest - Spokane SouthSpokane, Washington  99202
Decatur Memorial Hospital Cancer Care InstituteDecatur, Illinois  62526
Poudre Valley HospitalFort Collins, Colorado  80524
Cancer Center of Kansas, PA - Dodge CityDodge City, Kansas  67801
Minor and James Medical, PLLCSeattle, Washington  98104
Polyclinic First HillSeattle, Washington  98122
Welch Cancer Center at Sheridan Memorial HospitalSheridan, Wyoming  82801
Regional Cancer Center at Singing River HospitalPascagoula, Mississippi  39581
Cancer Center of Kansas, PA - ChanuteChanute, Kansas  66720
Cancer Center of Kansas, PA - El DoradoEl Dorado, Kansas  67042
Cancer Center of Kansas-IndependenceIndependence, Kansas  67301
Cancer Center of Kansas, PA - KingmanKingman, Kansas  67068
Cancer Center of Kansas, PA - NewtonNewton, Kansas  67114
Cancer Center of Kansas, PA - ParsonsParsons, Kansas  67357
Cancer Center of Kansas, PA - PrattPratt, Kansas  67124
Tammy Walker Cancer Center at Salina Regional Health CenterSalina, Kansas  67401
Cancer Center of Kansas, PA - SalinaSalina, Kansas  67401
Cancer Center of Kansas, PA - WellingtonWellington, Kansas  67152
Cancer Center of Kansas, PA - WichitaWichita, Kansas  67214
Associates in Womens Health, PA - North ReviewWichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts TowerWichita, Kansas  67208
Cancer Center of Kansas, PA - WinfieldWinfield, Kansas  67156
Billings Clinic - DowntownBillings, Montana  59107-7000
Bozeman Deaconess Cancer CenterBozeman, Montana  59715
St. James Healthcare Cancer CareButte, Montana  59701
Great Falls Clinic - Main FacilityGreat Falls, Montana  59405
Sletten Cancer Institute at Benefis HealthcareGreat Falls, Montana  59405
Northern Montana HospitalHavre, Montana  59501
Kalispell Medical Oncology at KRMCKalispell, Montana  59901
St. Joseph Cancer CenterBellingham, Washington  98225
Columbia Basin HematologyKennewick, Washington  99336
Regional Cancer Center at Memorial Medical CenterSpringfield, Illinois  62781-0001
Great Falls, Montana  59405
Guardian Oncology and Center for WellnessMissoula, Montana  59804
St. Vincent Healthcare Cancer Care ServicesBillings, Montana  59101