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Education With or Without Exercise and Counseling in Preventing Lymphedema in Women With Stage I, Stage II, or Stage III Breast Cancer Who Are Undergoing Axillary Lymph Node Dissection

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
No phase specifiedSupportive careActive18 and overNCI, OtherCDR0000494652
CALGB-70305, NCT00376597

Trial Description

Summary

RATIONALE: A personalized exercise program, counseling, and education materials may be more effective than education materials alone in preventing lymphedema in women with breast cancer who are undergoing axillary lymph node dissection.

PURPOSE: This randomized clinical trial is studying how well education with or without exercise and counseling works in preventing lymphedema in women with stage I, stage II, or stage III breast cancer who are undergoing axillary lymph node dissection.

Further Study Information

OBJECTIVES:

Primary

  • Determine the efficacy of a comprehensive program of tailored exercise, lymphedema prevention patient education, and counseling vs lymphedema prevention patient education only in reducing the incidence of lymphedema in women with stage I-III breast cancer who are undergoing axillary lymph node dissection.

Secondary

  • Compare the severity of lymphedema, in terms of changes in arm circumference at the site of greatest difference as a continuous variable, in patients undergoing these interventions.
  • Assess the agreement between patients' self-report of swelling (mild, moderate, or severe) and the extent of circumferential measurement difference between the treated side and the contralateral arm at the site of greatest difference (< 0.5 inches vs ≥ 0.5 and < 2 inches vs ≥ 2 inches).
  • Compare the health-related quality of life of these patients.
  • Characterize adherence to lymphedema prevention exercises, lymphedema knowledge, and range of motion.

OUTLINE: This is a randomized, controlled, multicenter study where the unit of randomization is the participating center. Participating centers are stratified according to the annual number of patients with stage I-III breast cancer who undergo axillary node dissection at the center (small vs moderate vs large number of patients) and are randomized to 1 of 2 arms. Patients are thus randomized to 1 of 2 intervention arms based on the identified participating center.

All patients complete questionnaires prior to surgery regarding lymphedema knowledge, health-related quality of life, fear of cancer recurrence, self-efficacy, body-image, self-report of range of motion, arm circumference, and demographics. Patients then undergo surgery, which must include axillary node dissection.

  • Arm I: Six weeks after surgery, patients receive a brief initial post-operative care session describing lymphedema risk and prevention through oral instruction and written materials. Patients complete physical assessments and questionnaires at 6 weeks and at 6, 12, and 18 months. Patients are also contacted by telephone at 9 and 15 months.
  • Arm II: Patients receive lymphedema education and complete physical assessments and questionnaires as in arm I. Patients also complete a personalized exercise regimen, receive a refrigerator magnet, and a 15-minute video that reinforces information and exercises.

PROJECTED ACCRUAL: A total of 560 patients will be accrued for this study.

Eligibility Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of breast cancer
  • Newly diagnosed disease
  • Stage I-III disease
  • No diagnosed lymphedema
  • Must have arm measurements for axilla, elbow, and wrist that fall within the ranges for one of six sleeve sizes (i.e., all three measurments must be found in one column) available
  • Scheduled to undergo axillary node dissection with ≥ 10 nodes removed
  • No sentinel axillary node dissection only
  • Hormone receptor status not specified

PATIENT CHARACTERISTICS:

  • Female
  • Menopausal status not specified
  • No documented cardiac conduction disturbances, unstable angina, dementia, or any other chronic disease that, in the opinion of the investigator, significantly increases mortality over the next 2 years
  • May not be currently homebound or dependent upon a walker or wheelchair for mobility
  • Able to participate in a mild exercise program
  • No prior history of carcinoma in situ, lobular carcinoma in situ, ductal carcinoma in situ, or invasive breast cancer
  • Patients with a history of other invasive malignancies are eligible as long as they have completed treatment and are 5 years post-diagnosis
  • Patients with basal cell and squamous cell carcinoma of the skin are eligible

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior double mastectomy, axillary node dissection, and/or radiotherapy involving both arms
  • Prior treatment (i.e., surgergy and/or radiotherapy) on the contralateral arm allowed provided it is documented appropriately
  • May be enrolled on other treatment trials except surgery trials where one treatment arm involves full axillary node dissection
  • Patients enrolled on ACOSOG-Z1071 allowed
  • Any type of radiotherapy to the breast or axilla allowed
  • Neoadjuvant treatment for this cancer allowed

Trial Contact Information

Trial Lead Organizations/Sponsors

Cancer and Leukemia Group B

National Cancer Institute

Electra D. PaskettStudy Chair

Trial Sites

U.S.A.
California
  Castro Valley
 East Bay Radiation Oncology Center
 James H. Feusner Ph: 510-450-7600
  Concord
 Cancer Care Center at John Muir Health - Concord Campus
 Deborah L. Kerlin Ph: 925-674-2580
  Martinez
 Contra Costa Regional Medical Center
 James H. Feusner Ph: 510-450-7600
  Mountain View
 El Camino Hospital Cancer Center
 James H. Feusner Ph: 510-450-7600
  Oakland
 Alta Bates Summit Medical Center - Summit Campus
 James H. Feusner Ph: 510-450-7600
 Bay Area Breast Surgeons, Incorporated
 James H. Feusner Ph: 510-450-7600
 CCOP - Bay Area Tumor Institute
 James H. Feusner Ph: 510-450-7600
 Highland General Hospital
 James H. Feusner Ph: 510-450-7600
 Larry G Strieff MD Medical Corporation
 James H. Feusner Ph: 510-450-7600
  Pleasanton
 Valley Medical Oncology Consultants - Pleasanton
 James H. Feusner Ph: 510-450-7600
  San Pablo
 Doctors Medical Center - San Pablo Campus
 James H. Feusner Ph: 510-450-7600
  Walnut Creek
 John Muir/Mt. Diablo Comprehensive Cancer Center
 Deborah L. Kerlin Ph: 925-674-2580
Connecticut
  Bridgeport
 St. Vincent's Medical Center
 Anthy Demestihas Ph: 888-823-5923
  Email: ctsucontact@westat.com
District of Columbia
  Washington
 Kaiser Permanente at Capitol Hill Medical Center
 Amadea Tette Ph: 888-823-5923
  Email: ctsucontact@westat.com
Florida
  Jupiter
 Ella Milbank Foshay Cancer Center at Jupiter Medical Center
 Michael Schwartz Ph: 305-674-2625
  Email: info@msccop.com
  Miami Beach
 CCOP - Mount Sinai Medical Center
 Michael Schwartz Ph: 305-674-2625
  Email: info@msccop.com
  Pensacola
 Sacred Heart Cancer Center at Sacred Heart Hospital
 Thomas D. Sunnenberg Ph: 850-416-4611
Illinois
  Chicago
 Resurrection Medical Center
 Lisa L Baddi Ph: 773-792-5116
 University of Chicago Cancer Research Center
 Gini F. Fleming Ph: 773-834-7424
  Harvey
 Ingalls Cancer Care Center at Ingalls Memorial Hospital
 Mark F. Kozloff Ph: 708-915-4673
  Email: clinicaltrials@ingalls.org
  Moline
 Garneau, Stewart C MD (UIA Investigator)
 Costas L. Constantinou Ph: 319-363-2690
 Porubcin, Michael MD (UIA Investigator)
 Costas L. Constantinou Ph: 319-363-2690
 Spector, David MD (UIA Investigator)
 Costas L. Constantinou Ph: 319-363-2690
 Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
 David M Spector Ph: 309-779-4200
Indiana
  La Porte
 Center for Cancer Therapy at LaPorte Hospital and Health Services
 Rafat H. Ansari Ph: 574-234-5123
  Mishawaka
 Saint Joseph's Medical Center
 Rafat H. Ansari Ph: 574-234-5123
  South Bend
 CCOP - Northern Indiana CR Consortium
 Rafat H. Ansari Ph: 574-234-5123
 Memorial Hospital of South Bend
 Rafat H. Ansari Ph: 574-234-5123
 Michiana Hematology-Oncology, PC - South Bend
 Rafat H. Ansari Ph: 574-234-5123
Iowa
  Bettendorf
 Constantinou, Costas L MD (UIA Investigator)
 Costas L. Constantinou Ph: 319-363-2690
Kansas
  Chanute
 Cancer Center of Kansas, PA - Chanute
 Shaker R. Dakhil Ph: 316-262-4467
  Dodge City
 Cancer Center of Kansas, PA - Dodge City
 Shaker R. Dakhil Ph: 316-262-4467
  El Dorado
 Cancer Center of Kansas, PA - El Dorado
 Shaker R. Dakhil Ph: 316-262-4467
  Fort Scott
 Cancer Center of Kansas - Fort Scott
 Shaker R. Dakhil Ph: 316-262-4467
  Independence
 Cancer Center of Kansas-Independence
 Shaker R. Dakhil Ph: 316-262-4467
  Kingman
 Cancer Center of Kansas, PA - Kingman
 Shaker R. Dakhil Ph: 316-262-4467
  Lawrence
 Lawrence Memorial Hospital
 Shaker R. Dakhil Ph: 316-262-4467
  Liberal
 Cancer Center of Kansas, PA - Liberal
 Shaker R. Dakhil Ph: 316-262-4467
  McPherson
 Cancer Center of Kansas, PA - McPherson
 Shaker R. Dakhil Ph: 316-262-4467
  Newton
 Cancer Center of Kansas, PA - Newton
 Shaker R. Dakhil Ph: 316-262-4467
  Parsons
 Cancer Center of Kansas, PA - Parsons
 Shaker R. Dakhil Ph: 316-262-4467
  Pratt
 Cancer Center of Kansas, PA - Pratt
 Shaker R. Dakhil Ph: 316-262-4467
  Salina
 Cancer Center of Kansas, PA - Salina
 Shaker R. Dakhil Ph: 316-262-4467
  Wellington
 Cancer Center of Kansas, PA - Wellington
 Shaker R. Dakhil Ph: 316-262-4467
  Wichita
 Associates in Women's Health, PA - North Hillside
 Shaker R. Dakhil Ph: 316-262-4467
 Cancer Center of Kansas, PA - Medical Arts Tower
 Shaker R. Dakhil Ph: 316-262-4467
 Cancer Center of Kansas, PA - Wichita
 Shaker R. Dakhil Ph: 316-262-4467
 CCOP - Wichita
 Shaker R. Dakhil Ph: 316-262-4467
 Via Christi Cancer Center at Via Christi Regional Medical Center
 Shaker R. Dakhil Ph: 316-262-4467
  Winfield
 Cancer Center of Kansas, PA - Winfield
 Shaker R. Dakhil Ph: 316-262-4467
Kentucky
  Lexington
 Central Baptist Hospital
 Peter S. Tate Ph: 859-260-6425
Maine
  York
 York Hospital's Oncology Treatment Center
 Jonathan D Eneman Ph: 207-351-3777
Maryland
  Baltimore
 Kaiser Permanente at Woodlawn Medical Center
 Amadea Tette Ph: 888-823-5923
  Email: ctsucontact@westat.com
  Gaithersburg
 Kaiser Permanente - Gaithersburg Medical Center
 Amadea Tette Ph: 888-823-5923
  Email: ctsucontact@westat.com
  Largo
 Kaiser Permanente Mid-Atlantic Medical Group-Largo Medical Facility
 Amadea Tette Ph: 888-823-5923
  Email: ctsucontact@westat.com
  Silver Spring
 Holy Cross Hospital
 Cheryl A. Aylesworth Ph: 301-896-2719
  Email: Bsquiller@suburbanhospital.org
Massachusetts
  Boston
 Tufts Medical Center Cancer Center
 Janice G Rothschild Ph: 617-636-5000
  Email: ContactUsCancerCenter@TuftsMedicalCenter.org
  Hyannis
 Davenport-Mugar Cancer Center at Cape Cod Hospital
 Frank G Basile Ph: 508-862-5799
Michigan
  Battle Creek
 Battle Creek Health System Cancer Care Center
 Gilbert D Padula Ph: 616-685-5225
  Grand Rapids
 Butterworth Hospital at Spectrum Health
 Gilbert D Padula Ph: 616-685-5225
 CCOP - Grand Rapids
 Gilbert D Padula Ph: 616-685-5225
 Lacks Cancer Center at Saint Mary's Health Care
 Gilbert D Padula Ph: 616-685-5225
  Muskegon
 Mercy General Health Partners
 Gilbert D Padula Ph: 616-685-5225
  Traverse City
 Munson Medical Center
 Gilbert D Padula Ph: 616-685-5225
North Carolina
  Goldsboro
 Wayne Memorial Hospital, Incorporated
 James N. Atkins Ph: 919-580-0000
North Dakota
  Fargo
 Roger Maris Cancer Center at MeritCare Hospital
 Preston D. Steen Ph: 701-234-6161
Pennsylvania
  Dubois
 Oncology Hematology Associates of Northern Pennsylvania, PC at Hahne Regional Cancer Center
 Carmine Marchioli Ph: 570-342-3675ext218
Texas
  Houston
 M. D. Anderson Cancer Center at University of Texas
 Jamie L Wagner
  Email: jwagner@mdanderson.org
 Univeristy of Texas M.D. Anderson Cancer Center
 Sarah M Gainer Ph: 713-792-3245
  Laredo
 Doctor's Hospital of Laredo
 Gary W. Unzeitig Ph: 888-823-5923
  Email: ctsucontact@westat.com
Virginia
  McLean
 Kaiser Permanente Tysons Corner Medical Center
 Amadea Tette Ph: 888-823-5923
  Email: ctsucontact@westat.com
West Virginia
  Huntington
 St. Mary's Regional Cancer Center at St. Mary's Medical Center
 James H Morgan
  Email: calgbco@calgb.org

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00376597
ClinicalTrials.gov processed this data on October 17, 2013

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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