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Last Modified: 10/30/2009     First Published: 9/10/2006  
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Randomized Study of Education With or Without Exercise and Counseling in Preventing Lymphedema in Women With Stage I-III Breast Cancer Who Are Undergoing Axillary Lymph Node Dissection

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Related Information
Registry Information

Alternate Title

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

PhaseTypeStatusAgeSponsorProtocol IDs
No phase specifiedSupportive care, TreatmentActive18 and overNCICALGB-70305
CALGB 70305, NCT00376597

Special Category: NCI Web site featured trial

Objectives

Primary

  1. 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

  1. 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.
  2. 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).
  3. Compare the health-related quality of life of these patients.
  4. Characterize adherence to lymphedema prevention exercises, lymphedema knowledge, range of motion, and arm strength.

Entry 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

Prior/Concurrent Therapy:

  • See Disease Characteristics
  • No prior double mastectomy, axillary node dissection, and/or radiotherapy involving both arms
  • May be enrolled on other treatment trials except surgery trials where one treatment arm involves full axillary node dissection
  • Any type of radiotherapy to the breast or axilla allowed
  • Neoadjuvant treatment for this cancer allowed

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

Expected Enrollment

560

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

Outcomes

Primary Outcome(s)

Lymphedema incidence (percentage of women who remain free from the presence of lymphedema for 18 months)

Secondary Outcome(s)

Severity of lymphedema as assessed by changes in arm circumference
Agreement between patients' self-report of swelling and the extent of circumferential measurement difference between the treated side and the contralateral arm
Health-related quality of life as assessed by Functional Assessment of Cancer Therapy-Breast (FACT-B) +4 score
Adherence to lymphedema prevention exercises, lymphedema knowledge, range of motion, and arm strength

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 and receive a 15-minute video that reinforces information and exercises.

Trial Contact Information

Trial Lead Organizations

Cancer and Leukemia Group B

Electra Paskett, PhD, Protocol chair
Ph: 614-293-3917
Email: electra.paskett@osumc.edu

Trial Sites

U.S.A.
California
  Castro Valley
 East Bay Radiation Oncology Center
 James Feusner, MD
Ph: 510-428-3689
 Eden Medical Center
 James Feusner, MD
Ph: 510-428-3689
 Valley Medical Oncology Consultants - Castro Valley
 James Feusner, MD
Ph: 510-428-3689
  Concord
 Cancer Care Center at John Muir Health - Concord Campus
 Clinical Trials Office - Cancer Care Center at John Muir Health - Concord Campus
Ph: 925-674-2580
  Fremont
 Valley Medical Oncology
 James Feusner, MD
Ph: 510-428-3689
  Martinez
 Contra Costa Regional Medical Center
 James Feusner, MD
Ph: 510-428-3689
  Mountain View
 El Camino Hospital Cancer Center
 Clinical Trials Office - El Camino Hospital Cancer Center
Ph: 650-988-7623
  Oakland
 Alta Bates Summit Medical Center - Summit Campus
 Clinical Trials Office - Alta Bates Summit Medical Center - Summit Campus
Ph: 510-204-1414
 Bay Area Breast Surgeons, Incorporated
 James Feusner, MD
Ph: 510-428-3689
 CCOP - Bay Area Tumor Institute
 James Feusner, MD
Ph: 510-428-3689
 Highland General Hospital
 James Feusner, MD
Ph: 510-428-3689
 Larry G Strieff MD Medical Corporation
 James Feusner, MD
Ph: 510-428-3689
 Tom K Lee, Incorporated
 James Feusner, MD
Ph: 510-428-3689
  Pleasanton
 Valley Care Medical Center
 James Feusner, MD
Ph: 510-428-3689
 Valley Medical Oncology Consultants - Pleasanton
 James Feusner, MD
Ph: 510-428-3689
  San Francisco
 UCSF Helen Diller Family Comprehensive Cancer Center
 Clinical Trials Office - UCSF Helen Diller Family Comprehensive Cancer Center
Ph: 877-827-3222
  San Pablo
 Doctors Medical Center - San Pablo Campus
 James Feusner, MD
Ph: 510-428-3689
Delaware
  Lewes
 Tunnell Cancer Center at Beebe Medical Center
 Clinical Trials Office - Tunnell Cancer Center
Ph: 302-645-3171
  Newark
 CCOP - Christiana Care Health Services
 Clinical Trial Office - CCOP - Christiana Care Health Services
Ph: 302-733-6227
District of Columbia
  Washington
 Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
 Clinical Trials Office - Lombardi Comprehensive Cancer Center
Ph: 202-444-0381
Illinois
  Chicago
 Resurrection Medical Center
 Lisa Baddi
Ph: 773-792-5116
877-737-4636
 University of Chicago Cancer Research Center
 Clinical Trials Office - University of Chicago Cancer Research Center
Ph: 773-834-7424
  Harvey
 Ingalls Cancer Care Center at Ingalls Memorial Hospital
 Clinical Trials Office - Ingalls Cancer Care Center at Ingalls Memorial Hospital
Ph: 708-915-6747
Kansas
  Anthony
 Hospital District Sixth of Harper County
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  Chanute
 Cancer Center of Kansas, PA - Chanute
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  Dodge City
 Cancer Center of Kansas, PA - Dodge City
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  El Dorado
 Cancer Center of Kansas, PA - El Dorado
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  Fort Scott
 Cancer Center of Kansas - Fort Scott
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  Independence
 Cancer Center of Kansas-Independence
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  Kingman
 Cancer Center of Kansas, PA - Kingman
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  Lawrence
 Lawrence Memorial Hospital
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  Liberal
 Southwest Medical Center
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  Newton
 Cancer Center of Kansas, PA - Newton
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  Parsons
 Cancer Center of Kansas, PA - Parsons
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  Pratt
 Cancer Center of Kansas, PA - Pratt
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  Salina
 Cancer Center of Kansas, PA - Salina
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  Wellington
 Cancer Center of Kansas, PA - Wellington
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  Wichita
 Associates in Womens Health, PA - North Review
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
 Cancer Center of Kansas, PA - Wichita
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
 Cancer Center of Kansas, PA - Medical Arts Tower
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
 CCOP - Wichita
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
 Via Christi Cancer Center at Via Christi Regional Medical Center
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  Winfield
 Cancer Center of Kansas, PA - Winfield
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
Maryland
  Elkton MD
 Union Hospital Cancer Program at Union Hospital
 Stephen Grubbs, MD
Ph: 302-366-1200
Michigan
  Battle Creek
 Battle Creek Health System Cancer Care Center
 Martin Bury
Ph: 616-966-8000
  Big Rapids
 Mecosta County Medical Center
 Martin Bury
Ph: 231-796-8691
  Grand Rapids
 Butterworth Hospital at Spectrum Health
 Martin Bury
Ph: 616-391-2799
 CCOP - Grand Rapids
 Martin Bury
Ph: 616-391-1230
 Lacks Cancer Center at Saint Mary's Health Care
 Martin Bury
Ph: 616-752-5222
  Muskegon
 Mercy General Health Partners
 Martin Bury
Ph: 231-672-2000
  Traverse City
 Munson Medical Center
 Martin Bury
Ph: 231-935-6202
  Wyoming
 Metro Health Hospital
 Martin Bury
Ph: 616-252-7200
New Jersey
  Voorhees
 Cancer Institute of New Jersey at Cooper - Voorhees
 Clinical Trials Office - Cancer Institute of New Jersey at Cooper University Hospital - Voorhees
Ph: 856-325-6757
North Carolina
  Goldsboro
 Wayne Memorial Hospital, Incorporated
 James Atkins, MD
Ph: 919-580-0000
  Winston-Salem
 Wake Forest University Comprehensive Cancer Center
 Clinical Trials Office - Wake Forest University Comprehensive Cancer Center
Ph: 336-713-6771
Ohio
  Columbus
 Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
 Ohio State University Cancer Clinical Trial Matching Service
Ph: 866-627-7616
 Email: osu@emergingmed.com
Pennsylvania
  Dubois
 Oncology Hematology Associates of Northern Pennsylvania, PC at Hahne Regional Cancer Center
 Carmine Marchioli, MD
Ph: 814-375-3535

Related Information

Featured trial article

Registry Information
Official Title A Randomized Study to Prevent Lymphedema in Women Treated for Breast Cancer
Trial Start Date 2006-06-30
Trial Completion Date 2012-12-31 (estimated)
Registered in ClinicalTrials.gov NCT00376597
Date Submitted to PDQ 2006-06-30
Information Last Verified 2009-10-30
NCI Grant/Contract Number CA77658

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

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