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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00090961
Other study ID # CDR0000380928
Secondary ID U10CA012027SWOG-
Status Terminated
Phase N/A
First received September 7, 2004
Last updated October 31, 2012
Start date September 2004
Est. completion date October 2008

Study information

Verified date October 2012
Source Southwest Oncology Group
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 2
Est. completion date October 2008
Est. primary completion date October 2008
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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

Study Design

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


Related Conditions & MeSH terms


Intervention

Other:
educational intervention

supervised exercise program


Locations

Country Name City State
United States St. Joseph Cancer Center Bellingham Washington
United States Billings Clinic - Downtown Billings Montana
United States CCOP - Montana Cancer Consortium Billings Montana
United States Hematology-Oncology Centers of the Northern Rockies - Billings Billings Montana
United States Northern Rockies Radiation Oncology Center Billings Montana
United States St. Vincent Healthcare Cancer Care Services Billings Montana
United States Bozeman Deaconess Cancer Center Bozeman Montana
United States Olympic Hematology and Oncology Bremerton Washington
United States St. James Healthcare Cancer Care Butte Montana
United States Cancer Center of Kansas, PA - Chanute Chanute Kansas
United States Decatur Memorial Hospital Cancer Care Institute Decatur Illinois
United States Barbara Ann Karmanos Cancer Institute Detroit Michigan
United States Cancer Center of Kansas, PA - Dodge City Dodge City Kansas
United States Cancer Center of Kansas, PA - El Dorado El Dorado Kansas
United States Poudre Valley Hospital Fort Collins Colorado
United States Wayne Memorial Hospital, Incorporated Goldsboro North Carolina
United States Big Sky Oncology Great Falls Montana
United States Great Falls Clinic - Main Facility Great Falls Montana
United States Sletten Cancer Institute at Benefis Healthcare Great Falls Montana
United States Northern Montana Hospital Havre Montana
United States St. Peter's Hospital Helena Montana
United States Cancer Center of Kansas-Independence Independence Kansas
United States Glacier Oncology, PLLC Kalispell Montana
United States Kalispell Medical Oncology at KRMC Kalispell Montana
United States Kalispell Regional Medical Center Kalispell Montana
United States Columbia Basin Hematology Kennewick Washington
United States Cancer Center of Kansas, PA - Kingman Kingman Kansas
United States Southwest Medical Center Liberal Kansas
United States Cardinal Bernardin Cancer Center at Loyola University Medical Center Maywood Illinois
United States Community Medical Center Missoula Montana
United States Guardian Oncology and Center for Wellness Missoula Montana
United States Montana Cancer Center at St. Patrick Hospital and Health Sciences Center Missoula Montana
United States Montana Cancer Specialists at Montana Cancer Center Missoula Montana
United States Cancer Center of Kansas, PA - Newton Newton Kansas
United States Cancer Center of Kansas, PA - Parsons Parsons Kansas
United States Regional Cancer Center at Singing River Hospital Pascagoula Mississippi
United States Cancer Center of Kansas, PA - Pratt Pratt Kansas
United States Cancer Center of Kansas, PA - Salina Salina Kansas
United States Tammy Walker Cancer Center at Salina Regional Health Center Salina Kansas
United States Fred Hutchinson Cancer Research Center Seattle Washington
United States Group Health Central Hospital Seattle Washington
United States Harborview Medical Center Seattle Washington
United States Minor and James Medical, PLLC Seattle Washington
United States Polyclinic First Hill Seattle Washington
United States Swedish Cancer Institute at Swedish Medical Center - First Hill Campus Seattle Washington
United States University Cancer Center at University of Washington Medical Center Seattle Washington
United States Welch Cancer Center at Sheridan Memorial Hospital Sheridan Wyoming
United States Cancer Care Northwest - Spokane South Spokane Washington
United States CCOP - Cancer Research for the Ozarks Springfield Missouri
United States Hulston Cancer Center at Cox Medical Center South Springfield Missouri
United States Regional Cancer Center at Memorial Medical Center Springfield Illinois
United States St. John's Regional Health Center Springfield Missouri
United States Cancer Center of Kansas, PA - Wellington Wellington Kansas
United States Associates in Womens Health, PA - North Review Wichita Kansas
United States Cancer Center of Kansas, PA - Medical Arts Tower Wichita Kansas
United States Cancer Center of Kansas, PA - Wichita Wichita Kansas
United States CCOP - Wichita Wichita Kansas
United States Via Christi Cancer Center at Via Christi Regional Medical Center Wichita Kansas
United States Cancer Center of Kansas, PA - Winfield Winfield Kansas

Sponsors (2)

Lead Sponsor Collaborator
Southwest Oncology Group National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Exercise tolerance comparison between the control and intervention arms in the percent change in the 6-minute walk distance between baseline and 6 months. Baseline and at 6 months No
Secondary Health-related quality of life The difference in total score between pre-study and 6 months for the FACT-L Quality of Life measure. Baseline and at 6 months. No
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