Clinical Trial: Pulmonary Rehabilitation Education With or Without Exercise Training in Improving Physical Function in Patients Who Are Undergoing Chemotherapy and Radiation Therapy for Locally Advanced Non-Small Cell Lung Cancer

This study is currently recruiting patients.

Sponsors and Collaborators: Southwest Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

Purpose

RATIONALE: Pulmonary rehabilitation education and exercise training may improve physical function and quality of life in patients who are receiving treatment for non-small cell 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 non-small cell lung cancer.

Condition Treatment or Intervention
Adenocarcinoma of the Lung
Bronchoalveolar Cell Lung Cancer
large cell lung cancer
Non-small cell lung cancer
Pulmonary Complications
Squamous Cell Lung Cancer
 Procedure: cancer prevention intervention
 Procedure: complications of therapy assessment/management
 Procedure: dyspnea management
 Procedure: educational intervention
 Procedure: supportive care/therapy

MedlinePlus related topics:  Lung Cancer

Study Type: Interventional
Study Design: Treatment

Official Title: Randomized Study of Pulmonary Rehabilitation Comprising Education With or Without Exercise Training in Patients With Inoperable Locally Advanced Non-Small Cell Lung Cancer Undergoing Chemoradiotherapy

Further Study Details: 

OBJECTIVES:

  • Compare improvement in physiologic function, in terms of exercise tolerance, in patients with inoperable locally advanced non-small cell 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); randomization on (gefitinib vs placebo); and smoking status* (never smoked or former smoker vs current smoker). Approximately 20 weeks into treatment on , 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

Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed single, primary bronchogenic non-small cell 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
  • Registered to
  • Eligible for randomization to gefitinib vs placebo

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 neuropathygrade 2
  • No uncontrolled diabetes mellitus
  • No other medical condition that would preclude study participation

PRIOR CONCURRENT THERAPY: Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified

Location and Contact Information


Alabama
      MBCCOP - Gulf Coast, Mobile,  Alabama,  36607,  United States; Recruiting
Paul O. Schwarzenberger, MD  251-544-1013 

Arizona
      Arizona Cancer Center at University of Arizona Health Sciences Center, Tucson,  Arizona,  85724,  United States; Recruiting
Thomas P. Miller, MD  520-626-2667 

      CCOP - Western Regional, Arizona, Phoenix,  Arizona,  85006-2726,  United States; Recruiting
David Kyle King, MD, FACP  602-239-2413    david.king@baannerhealth.com 

      Veterans Affairs Medical Center - Phoenix (Carl T. Hayden), Phoenix,  Arizona,  85012,  United States; Recruiting
Thomas Dale Kummet, MD  602-277-5551 

      Veterans Affairs Medical Center - Tucson, Tucson,  Arizona,  85723,  United States; Recruiting
Harinder S. Garewal, MD  520-629-4686 

Arkansas
      Arkansas Cancer Research Center at University of Arkansas for Medical Sciences, Little Rock,  Arkansas,  72205,  United States; Recruiting
Laura Fulper Hutchins, MD  501-686-8511    LFHutchins@uams.edu 

      Veterans Affairs Medical Center - Little Rock, Little Rock,  Arkansas,  72205,  United States; Recruiting
Bart Barlogie, MD  501-526-2873 

California
      CCOP - Bay Area Tumor Institute, Oakland,  California,  94609-3305,  United States; Recruiting
Joseph Szumowski, MD  510-465-8570 

      CCOP - Santa Rosa Memorial Hospital, Santa Rosa,  California,  95403,  United States; Recruiting
Ian C. Anderson, MD  707-521-3830 

      Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center, Orange,  California,  92868,  United States; Recruiting
Randall F. Holcombe, MD  714-456-5153    rholcomb@uci.edu 

      City of Hope Comprehensive Cancer Center, Duarte,  California,  91010-3000,  United States; Recruiting
Clinical Trials Office - New Patient Services  800-826-4673    becomingapatient@coh.org 

      General Robert Huyser Cancer Center at David Grant Medical Center, Travis Air Force Base,  California,  94535,  United States; Recruiting
Kevin P. Ryan, MD  707-423-5129    ryan_k@comcast.net 

      Jonsson Comprehensive Cancer Center, UCLA, Los Angeles,  California,  90095-1781,  United States; Recruiting
John L. Barstis, MD  310-825-5268 

      Loma Linda University Cancer Institute at Loma Linda University Medical Center, Loma Linda,  California,  92354,  United States; Recruiting
Jesus G. Berdeja, MD  909-558-4910 

      University of California Davis Cancer Center, Sacramento,  California,  95817,  United States; Recruiting
David R. Gandara, MD  916-734-3772    dgandara@cc.ucdmc.ucdavis.edu 

      USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles,  California,  90033,  United States; Recruiting
Heinz-Josef Lenz, MD  323-865-3955    lenz@usc.edu 

      Veterans Affairs Outpatient Clinic - Martinez, Martinez,  California,  94553,  United States; Recruiting
David R. Gandara, MD  925-372-2064 

Colorado
      University of Colorado Cancer Center at University of Colorado Health Sciences Center, Aurora,  Colorado,  80010,  United States; Recruiting
Anthony D. Elias, MD  720-848-1622    Anthony.Elias@uchsc.edu 

      Veterans Affairs Medical Center - Denver, Denver,  Colorado,  80220,  United States; Recruiting
Madeleine A. Kane, MD, PhD  303-399-8020 ext. 3129    madeleine.kane@med.va.gov 

District of Columbia
      MBCCOP - Howard University Cancer Center, Washington,  District of Columbia,  20060,  United States; Recruiting
Lucile L. Adams-Campbell, PhD  202-806-7697 

Georgia
      CCOP - Atlanta Regional, Atlanta,  Georgia,  30342-1701,  United States; Recruiting
Thomas E. Seay, MD, PhD  404-851-2340 

      Dwight David Eisenhower Army Medical Center, Fort Gordon,  Georgia,  30905-5650,  United States; Recruiting
Kenneth I. Fink, MD  706-787-2527    kenneth.fink@se.amedd.army.mil 

Hawaii
      MBCCOP - Hawaii, Honolulu,  Hawaii,  96813,  United States; Recruiting
Brian F. Issell, MD  808-586-3015    brian@crch.hawaii.edu 

Illinois
      Cardinal Bernardin Cancer Center at Loyola University Medical Center, Maywood,  Illinois,  60153-5500,  United States; Recruiting
Patrick J. Stiff, MD  708-327-3148 

      CCOP - Central Illinois, Decatur,  Illinois,  62526,  United States; Recruiting
James L. Wade, MD  217-876-6617    jlwade3@sbcglobal.net 

      MBCCOP - University of Illinois at Chicago, Chicago,  Illinois,  60612,  United States; Recruiting
Lawrence Eric Feldman, MD  312-335-3614 

      Robert H. Lurie Comprehensive Cancer Center at Northwestern University, Chicago,  Illinois,  60611,  United States; Recruiting
David A. Fishman, MD  312-926-7365 

      Veterans Affairs Medical Center - Chicago (Westside Hospital), Chicago,  Illinois,  60612,  United States; Recruiting
Lawrence Eric Feldman, MD  312-569-6129 

      Veterans Affairs Medical Center - Hines, Hines,  Illinois,  60141,  United States; Recruiting
Nirmala Bhoopalam, MD  708-202-2782 

Kansas
      CCOP - Wichita, Wichita,  Kansas,  67214-3882,  United States; Recruiting
Shaker R. Dakhil, MD, FACP  316-268-5784 

      Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center, Kansas City,  Kansas,  66160-7353,  United States; Recruiting
Sarah A. Taylor, MD  913-588-6029    sataylor@kumc.edu 

      Veterans Affairs Medical Center - Wichita, Wichita,  Kansas,  67218,  United States; Recruiting
Shaker R. Dakhil, MD, FACP  316-685-2221 

Kentucky
      Markey Cancer Center at University of Kentucky Chandler Medical Center, Lexington,  Kentucky,  40536-0084,  United States; Recruiting
Michael A. Doukas, MD  859-257-3379 

      Veterans Affairs Medical Center - Lexington, Lexington,  Kentucky,  40502-2236,  United States; Recruiting
Michael A. Doukas, MD  859-281-4956 

Louisiana
      Louisiana State University Health Sciences Center - Shreveport, Shreveport,  Louisiana,  71130-3932,  United States; Recruiting
Glenn M. Mills, MD  318-675-5970    gmills@lsuhsc.edu 

      MBCCOP - LSU Health Sciences Center, New Orleans,  Louisiana,  70112,  United States; Recruiting
Jill Gilbert, MD  504-568-5613    jgilbe@lsuhsc.edu 

      Tulane Cancer Center at Tulane University Hospital and Clinic, New Orleans,  Louisiana,  70112,  United States; Recruiting
Alan M. Miller, MD, PhD  504-587-7566    amiller@tulane.edu 

      Veterans Affairs Medical Center - New Orleans, New Orleans,  Louisiana,  70112,  United States; Recruiting
German S. Beltran, MD  504-588-5482 

      Veterans Affairs Medical Center - Shreveport, Shreveport,  Louisiana,  71101-4295,  United States; Recruiting
Glenn M. Mills, MD  318-221-8411 

Massachusetts
      Cancer Research Center at Boston Medical Center, Boston,  Massachusetts,  02118,  United States; Recruiting
Douglas V. Faller, MD, PhD  617-638-4173 

Michigan
      Barbara Ann Karmanos Cancer Institute, Detroit,  Michigan,  48201-1379,  United States; Recruiting
Lawrence E. Flaherty, MD  313-745-9155    flaherty@karmanos.org 

      CCOP - Beaumont, Royal Oak,  Michigan,  48073-6769,  United States; Recruiting
Jeanne Archer, PhD, APN  248-551-8299    carcher@beaumon.edu 

      CCOP - Grand Rapids, Grand Rapids,  Michigan,  49503,  United States; Recruiting
Kathleen Jo Yost, MD  616-391-1230 

      CCOP - Michigan Cancer Research Consortium, Ann Arbor,  Michigan,  48106,  United States; Recruiting
Philip J. Stella, MD  734-712-5237 

      Josephine Ford Cancer Center at Henry Ford Health System, Detroit,  Michigan,  48202,  United States; Recruiting
Robert Anthony Chapman, MD  313-916-1332    rchapma1@hfhs.org 

      Providence Cancer Institute at Providence Hospital - Southfield, Southfield,  Michigan,  48075,  United States; Recruiting
Anibal Drelichman, MD, MPH, FACP  313-552-0620    adrelichman@yahoo.com 

      University of Michigan Comprehensive Cancer Center, Ann Arbor,  Michigan,  48109-0948,  United States; Recruiting
Laurence H. Baker, DO, FACOI  734-936-3983    bakerl@umich.edu 

      Veterans Affairs Medical Center - Detroit, Detroit,  Michigan,  48201-1932,  United States; Recruiting
Lawrence E. Flaherty, MD  313-576-1000 

Mississippi
      University of Mississippi Medical Center, Jackson,  Mississippi,  39216-4505,  United States; Recruiting
James Tate Thigpen, MD  601-984-5590    jthigpen@medicine.umsmed.edu 

      Veterans Affairs Medical Center - Jackson, Jackson,  Mississippi,  39216,  United States; Recruiting
James Tate Thigpen, MD  601-362-4471 

Missouri
      CCOP - Cancer Research for the Ozarks, Springfield,  Missouri,  65807,  United States; Recruiting
John Wendall Goodwin, MD  417-269-4520    jwg684@sprg.mercy.net 

      CCOP - Kansas City, Kansas City,  Missouri,  64131,  United States; Recruiting
William T. Stephenson, MD  816-823-0555 

      CCOP - St. Louis-Cape Girardeau, Saint Louis,  Missouri,  63141,  United States; Recruiting
Bethany G. Sleckman, MD  314-569-6573 

      Saint Louis University Cancer Center, Saint Louis,  Missouri,  63110,  United States; Recruiting
Paul J. Petruska, MD  314-268-5451    petruspj@slu.edu 

      Veterans Affairs Medical Center - Kansas City, Kansas City,  Missouri,  64128,  United States; Recruiting
Peter J. VanVeldhuizen, MD  816-861-4700 ext. 6775    peter.vanveldhuizen@med.va.gov 

Montana
      CCOP - Montana Cancer Consortium, Billings,  Montana,  59101,  United States; Recruiting
Patrick W. Cobb, MD  406-259-2245 

New Mexico
      MBCCOP - University of New Mexico HSC, Albuquerque,  New Mexico,  87131,  United States; Recruiting
Cheryl L. Willman, MD  505-272-5837 

      Veterans Affairs Medical Center - Albuquerque, Albuquerque,  New Mexico,  87108-5138,  United States; Recruiting
Cheryl L. Willman, MD  505-265-1711 

New York
      Herbert Irving Comprehensive Cancer Center at Columbia University, New York,  New York,  10032,  United States; Recruiting
Mitchell C. Benson, MD  212-305-5201    mcb2@columbia.edu 

      James P. Wilmot Cancer Center at University of Rochester Medical Center, Rochester,  New York,  14642,  United States; Recruiting
Richard I. Fisher, MD  585-275-0842    richard_fisher@urmc.rochester.edu 

      NYU Cancer Institute at New York University Medical Center, New York,  New York,  10016,  United States; Recruiting
Amy D. Tiersten, MD  212-652-1916 

North Carolina
      CCOP - Southeast Cancer Control Consortium, Goldsboro,  North Carolina,  27534-9479,  United States; Recruiting
James N. Atkins, MD  336-777-3088 

Ohio
      Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University, Columbus,  Ohio,  43210-1240,  United States; Recruiting
David E. Schuller, MD  614-293-4878    schuller-l@medctr.osu.edu 

      CCOP - Columbus, Columbus,  Ohio,  43206,  United States; Recruiting
J. Philip Kuebler, MD, PhD  614-488-2118 

      CCOP - Dayton, Dayton,  Ohio,  45429,  United States; Recruiting
Howard M. Gross, MD  937-832-1093 

      Charles M. Barrett Cancer Center at University Hospital, Cincinnati,  Ohio,  45267-0501,  United States; Recruiting
Abdul-Rahman Jazieh, MD, MPH  513-584-3830 

      Cleveland Clinic Taussig Cancer Center, Cleveland,  Ohio,  44195-9001,  United States; Recruiting
George Thomas Budd, MD  216-444-6480 

      Veterans Affairs Medical Center - Cincinnati, Cincinnati,  Ohio,  45220-2288,  United States; Recruiting
Albert F. Muhleman, MD  513-475-6537    albert.muhleman@med.va.gov 

      Veterans Affairs Medical Center - Dayton, Dayton,  Ohio,  45428-1002,  United States; Recruiting
Howard M. Gross, MD  937-268-6511 

Oklahoma
      Oklahoma University Medical Center, Oklahoma City,  Oklahoma,  73104,  United States; Recruiting
Howard Ozer, MD, PhD  405-271-4022 

Oregon
      Cancer Institute at Oregon Health and Science University, Portland,  Oregon,  97201-3098,  United States; Recruiting
Craig R. Nichols, MD  503-494-6346 

      CCOP - Columbia River Oncology Program, Portland,  Oregon,  97225,  United States; Recruiting
Keith S. Lanier, MD  503-216-6260 

      Veterans Affairs Medical Center - Portland, Portland,  Oregon,  97207,  United States; Recruiting
Christopher W. Ryan, MD  503-220-8262 

South Carolina
      CCOP - Greenville, Greenville,  South Carolina,  29615,  United States; Recruiting
Jeffrey Kent Giguere, MD  864-241-6251 

      CCOP - Upstate Carolina, Spartanburg,  South Carolina,  29303,  United States; Recruiting
James Dewitt Bearden, MD  864-560-7050 

      Hollings Cancer Center at Medical University of South Carolina, Charleston,  South Carolina,  29425,  United States; Recruiting
Carolyn E. Reed, MD  843-792-9321    reedce@musc.edu 

      Veterans Affairs Medical Center - Charleston, Charleston,  South Carolina,  29401-5799,  United States; Recruiting
Carolyn E. Reed, MD  843-789-7804 

Tennessee
      University of Tennessee Cancer Institute at Methodist Central Hospital, Memphis,  Tennessee,  38104,  United States; Recruiting
Mohammad Jahanzeb, MD  901-722-0532 

      Veterans Affairs Medical Center - Memphis, Memphis,  Tennessee,  38104,  United States; Recruiting
Harvey B. Niell, MD  901-523-8990 ext. 5533 

Texas
      Baylor College of Medicine, Houston,  Texas,  77030,  United States; Recruiting
Seth P. Lerner, MD  713-798-6841 

      Brooke Army Medical Center, Fort Sam Houston,  Texas,  78234-6200,  United States; Recruiting
Mitchell A. Garrison, MD  210-916-3281    mitchell.garrison@cen.amedd.army.mil 

      CCOP - Scott and White Hospital, Temple,  Texas,  76508,  United States; Recruiting
Lucas Wong, MD  254-724-1053    lwong@swmail.sw.org 

      Harrington Cancer Center, Amarillo,  Texas,  79106,  United States; Recruiting
James E. Clarkson, MD  806-359-4673 ext. 228    jclarkson@harringtoncc.org 

      MD Anderson Cancer Center at University of Texas, Houston,  Texas,  77030-4095,  United States; Recruiting
Scott Michael Lippman, MD, FACP  713-745-3672 

      Southwest Cancer and Research Center at University Medical Center, Lubbock,  Texas,  79415-3364,  United States; Recruiting
Werner T. W. DeRiese, MD, PhD  806-775-8590    werner.deriese@ttumc.ttuhsc.edu 

      University of Texas Medical Branch, Galveston,  Texas,  77555-0565,  United States; Recruiting
Robert P. Whitehead, MD  409-772-1164    rpwhiteh@utmb.edu 

      Veterans Affairs Medical Center - Amarillo, Amarillo,  Texas,  79106,  United States; Recruiting
Stephen E. Wright, MD  806-359-4673 ext. 230 

      Veterans Affairs Medical Center - San Antonio (Murphy), San Antonio,  Texas,  78229,  United States; Recruiting
Geoffrey R. Weiss, MD  210-617-5186 

      Veterans Affairs Medical Center - Temple, Temple,  Texas,  76504,  United States; Recruiting
Phalguni Mukhopadhyay, MD  254-778-4811 ext. 4809 

Utah
      Huntsman Cancer Institute at University of Utah, Salt Lake City,  Utah,  84112-5550,  United States; Recruiting
Wolfram Samlowski, MD  801-585-0255    wolfram.samlowski@hci.utah.edu 

      Utah Valley Regional Medical Center - Provo, Provo,  Utah,  84604,  United States; Recruiting
Jay Cordell Bott, MD  801-321-1030 

      Veterans Affairs Medical Center - Salt Lake City, Salt Lake City,  Utah,  84148,  United States; Recruiting
Wolfram Samlowski, MD  801-582-1565 ext. 1272 

Virginia
      Massey Cancer Center at Virginia Commonwealth University, Richmond,  Virginia,  23298,  United States; Recruiting
John D. Roberts, MD  804-828-0450    john.d.roberts@vcu.edu 

Washington
      CCOP - Northwest, Tacoma,  Washington,  98405-0986,  United States; Recruiting
Lauren Kenneth Colman, MD  253-403-5259    lauren.colman@multicare.org 

      CCOP - Virginia Mason Research Center, Seattle,  Washington,  98101,  United States; Recruiting
Andrew David Jacobs, MD  206-341-0446 

      Madigan Army Medical Center, Tacoma,  Washington,  98431-5000,  United States; Recruiting
Rajat Bannerji, MD, PhD  253-968-2504 

      Swedish Cancer Institute at Swedish Medical Center - First Hill Campus, Seattle,  Washington,  98104,  United States; Recruiting
Saul E. Rivkin, MD  206-386-2441    saul.rivkin@swedish.org 

      Veterans Affairs Medical Center - Seattle, Seattle,  Washington,  98108,  United States; Recruiting
William H. Schubach, MD  206-764-2265 

Study chairs or principal investigators

Antoinette J. Wozniak, MD,  Study Chair,  Barbara Ann Karmanos Cancer Institute   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000380928; SWOG-S0229; NCT00090961
Record last reviewed:  November 2004
Last Updated:  April 4, 2005
Record first received:  September 7, 2004
ClinicalTrials.gov Identifier:  NCT00090961
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005