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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by National Cancer Institute (NCI)
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00376597
First received: September 13, 2006
Last updated: December 19, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention
Breast Cancer
Lymphedema
Perioperative/Postoperative Complications
Behavioral: exercise intervention
Other: educational intervention
Procedure: assessment of therapy complications
Procedure: complementary or alternative medicine procedure
Procedure: management of therapy complications
Procedure: quality-of-life assessment
Procedure: therapeutic conventional surgery

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Supportive Care
Official Title: A Randomized Study to Prevent Lymphedema in Women Treated for Breast Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Lymphedema incidence (percentage of women who remain free from the presence of lymphedema for 18 months) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Severity of lymphedema as assessed by changes in arm circumference [ Designated as safety issue: No ]
  • Agreement between patients' self-report of swelling and the extent of circumferential measurement difference between the treated side and the contralateral arm [ Designated as safety issue: No ]
  • Health-related quality of life as assessed by Functional Assessment of Cancer Therapy-Breast (FACT-B) +4 score [ Designated as safety issue: No ]
  • Adherence to lymphedema prevention exercises, lymphedema knowledge, range of motion, and arm strength [ Designated as safety issue: No ]

Estimated Enrollment: 560
Study Start Date: June 2006
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Detailed Description:

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00376597

  Hide Study Locations
Locations
United States, California
East Bay Radiation Oncology Center Recruiting
Castro Valley, California, United States, 94546
Contact: James H. Feusner, MD    510-428-3689      
Valley Medical Oncology Consultants - Castro Valley Recruiting
Castro Valley, California, United States, 94546
Contact: James H. Feusner, MD    510-428-3689      
Cancer Care Center at John Muir Health - Concord Campus Recruiting
Concord, California, United States, 94524-4110
Contact: Clinical Trials Office - Cancer Care Center at John Muir Healt    925-674-2580      
Valley Medical Oncology Recruiting
Fremont, California, United States, 94538
Contact: James H. Feusner, MD    510-428-3689      
Contra Costa Regional Medical Center Recruiting
Martinez, California, United States, 94553-3156
Contact: James H. Feusner, MD    510-428-3689      
El Camino Hospital Cancer Center Recruiting
Mountain View, California, United States, 94040
Contact: Clinical Trials Office - El Camino Hospital Cancer Center    650-988-7623      
Alta Bates Summit Medical Center - Summit Campus Recruiting
Oakland, California, United States, 94609
Contact: Clinical Trials Office - Alta Bates Summit Medical Center - Su    510-204-1414      
CCOP - Bay Area Tumor Institute Recruiting
Oakland, California, United States, 94609
Contact: James H. Feusner, MD    510-428-3689      
Highland General Hospital Recruiting
Oakland, California, United States, 94602
Contact: James H. Feusner, MD    510-428-3689      
Bay Area Breast Surgeons, Incorporated Recruiting
Oakland, California, United States, 94609
Contact: James H. Feusner, MD    510-428-3689      
Larry G Strieff MD Medical Corporation Recruiting
Oakland, California, United States, 94609
Contact: James H. Feusner, MD    510-428-3689      
Tom K Lee, Incorporated Recruiting
Oakland, California, United States, 94609
Contact: James H. Feusner, MD    510-428-3689      
Doctors Medical Center - San Pablo Campus Recruiting
San Pablo, California, United States, 94806
Contact: James H. Feusner, MD    510-428-3689      
John Muir/Mt. Diablo Comprehensive Cancer Center Recruiting
Walnut Creek, California, United States, 94598
Contact: Clinical Trials Office - John Muir/Mt. Diablo Comprehensive Ca    925-941-4246      
United States, Delaware
Tunnell Cancer Center at Beebe Medical Center Recruiting
Lewes, Delaware, United States, 19958
Contact: Clinical Trials Office - Tunnell Cancer Center    302-645-3171      
CCOP - Christiana Care Health Services Recruiting
Newark, Delaware, United States, 19713
Contact: Clinical Trial Office - CCOP - Christiana Care Health Services    302-623-4450      
United States, District of Columbia
Kaiser Permanente at Capitol Hill Medical Center Recruiting
Washington, District of Columbia, United States, 20002
Contact: Amadea Tette    703-359-7878      
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center Recruiting
Washington, District of Columbia, United States, 20007
Contact: Clinical Trials Office - Lombardi Comprehensive Cancer Center    202-444-0381      
United States, Florida
North Broward Medical Center Recruiting
Dearfield Beach, Florida, United States, 33064-3596
Contact: Clinical Trials Office - North Broward Medical Center    954-941-8300      
Ella Milbank Foshay Cancer Center at Jupiter Medical Center Recruiting
Jupiter, Florida, United States, 33458
Contact: Clinical Trials Office - Ella Milbank Foshay Cancer Center    561-745-5768      
CCOP - Mount Sinai Medical Center Recruiting
Miami Beach, Florida, United States, 33140
Contact: Michael Schwartz, MD    305-535-3310      
Sacred Heart Cancer Center at Sacred Heart Hospital Recruiting
Pensacola, Florida, United States, 32504
Contact: Clinical Trials Office - Sacred Heart Cancer Center    850-416-4611      
Tallahassee Memorial Hospital Recruiting
Tallahassee, Florida, United States, 32308
Contact: Shelby L. Blank    850-431-1155      
United States, Illinois
University of Chicago Cancer Research Center Recruiting
Chicago, Illinois, United States, 60637-1470
Contact: Clinical Trials Office - University of Chicago Cancer Research    773-834-7424      
Resurrection Medical Center Recruiting
Chicago, Illinois, United States, 60631
Contact: Lisa L. Baddi    773-792-5116      
Alexian Brothers Radiation Oncology Recruiting
Elk Grove Village, Illinois, United States, 60007
Contact: Alkarim Tajuddin    847-981-5760      
Ingalls Cancer Care Center at Ingalls Memorial Hospital Recruiting
Harvey, Illinois, United States, 60426
Contact: Clinical Trials Office - Ingalls Cancer Care Center at Ingalls    708-915-4673      
Recruiting
Moline, Illinois, United States, 61265
Contact: Costas L. Constantinou, MD    563-359-9876      
Trinity Cancer Center at Trinity Medical Center - 7th Street Campus Recruiting
Moline, Illinois, United States, 61265
Contact: Costas L. Constantinou, MD    563-359-9876      
United States, Indiana
Center for Cancer Therapy at LaPorte Hospital and Health Services Recruiting
La Porte, Indiana, United States, 46350
Contact: Rafat H. Ansari, MD, FACP    574-234-5123      
Saint Joseph Regional Medical Center Recruiting
Mishawaka, Indiana, United States, 46545-1470
Contact: Rafat H. Ansari, MD, FACP    574-234-5123      
Memorial Hospital of South Bend Recruiting
South Bend, Indiana, United States, 46601
Contact: Clinical Trials Office - Memorial Hospital of South Bend    800-284-7370      
Michiana Hematology-Oncology, PC - South Bend Recruiting
South Bend, Indiana, United States, 46601
Contact: Rafat H. Ansari, MD, FACP    574-234-5123      
CCOP - Northern Indiana CR Consortium Recruiting
South Bend, Indiana, United States, 46601
Contact: Rafat H. Ansari, MD, FACP    574-234-5123      
United States, Iowa
Recruiting
Bettendorf, Iowa, United States, 52722
Contact: Costas L. Constantinou, MD    563-359-9876      
United States, Kansas
Cancer Center of Kansas, PA - Chanute Recruiting
Chanute, Kansas, United States, 66720
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
Cancer Center of Kansas, PA - Dodge City Recruiting
Dodge City, Kansas, United States, 67801
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
Cancer Center of Kansas, PA - El Dorado Recruiting
El Dorado, Kansas, United States, 67042
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
Cancer Center of Kansas - Fort Scott Recruiting
Fort Scott, Kansas, United States, 66701
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
Cancer Center of Kansas-Independence Recruiting
Independence, Kansas, United States, 67301
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
Cancer Center of Kansas, PA - Kingman Recruiting
Kingman, Kansas, United States, 67068
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
Lawrence Memorial Hospital Recruiting
Lawrence, Kansas, United States, 66044
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
Cancer Center of Kansas, PA - Liberal Recruiting
Liberal, Kansas, United States, 67901
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
Cancer Center of Kansas, PA - McPherson Recruiting
McPherson, Kansas, United States, 67460
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
Cancer Center of Kansas, PA - Newton Recruiting
Newton, Kansas, United States, 67114
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
Cancer Center of Kansas, PA - Parsons Recruiting
Parsons, Kansas, United States, 67357
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
Cancer Center of Kansas, PA - Pratt Recruiting
Pratt, Kansas, United States, 67124
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
Cancer Center of Kansas, PA - Salina Recruiting
Salina, Kansas, United States, 67401
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
Cancer Center of Kansas, PA - Wellington Recruiting
Wellington, Kansas, United States, 67152
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
Cancer Center of Kansas, PA - Wichita Recruiting
Wichita, Kansas, United States, 67214
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
Cancer Center of Kansas, PA - Medical Arts Tower Recruiting
Wichita, Kansas, United States, 67208
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
CCOP - Wichita Recruiting
Wichita, Kansas, United States, 67214
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
Associates in Womens Health, PA - North Review Recruiting
Wichita, Kansas, United States, 67208
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
Via Christi Cancer Center at Via Christi Regional Medical Center Recruiting
Wichita, Kansas, United States, 67214
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
Cancer Center of Kansas, PA - Winfield Recruiting
Winfield, Kansas, United States, 67156
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
United States, Kentucky
Central Baptist Hospital Recruiting
Lexington, Kentucky, United States, 40503-9985
Contact: Clinical Trials Office - Central Baptist Hospital    859-260-6425      
United States, Maine
York Hospital's Oncology Treatment Center Recruiting
York, Maine, United States, 03909
Contact: Jonathan D. Eneman    207-351-3777      
United States, Maryland
Kaiser Permanente at Woodlawn Medical Center Recruiting
Baltimore, Maryland, United States, 21244
Contact: Amadea Tette    443-663-6000      
Union Hospital of Cecil County Recruiting
Elkton MD, Maryland, United States, 21921
Contact: Stephen S. Grubbs, MD    302-366-1200      
Kaiser Permanente - Gaithersburg Medical Center Recruiting
Gaithersburg, Maryland, United States, 20879
Contact: Amadea Tette    240-632-4000      
Kaiser Permanente Mid-Atlantic Medical Group-Largo Medical Facility Recruiting
Largo, Maryland, United States, 20774
Contact: Amadea Tette    301-618-5500      
Holy Cross Hospital Recruiting
Silver Spring, Maryland, United States, 20910
Contact: Clinical Trials Office - Holy Cross Hospital    310-754-7552      
United States, Massachusetts
Tufts Medical Center Cancer Center Recruiting
Boston, Massachusetts, United States, 02111
Contact: Janice G. Rothschild    617-636-6100      
Cape Cod Hospital Recruiting
Hyannis, Massachusetts, United States, 02601
Contact: Frank G. Basile    508-771-1800      
United States, New Jersey
Trinitas Comprehensive Cancer Center at Trinitas Hospital Recruiting
Elizabeth, New Jersey, United States, 07207
Contact: Clarissa F. Henson    908-994-5000      
AtlantiCare Cancer Care Institute at AtlantiCare Regional Medical Center - Mainland Campus Recruiting
Galloway, New Jersey, United States, 08240
Contact: Julianne W. Childs, DO, FACOI    609-390-7888      
Cancer Institute of New Jersey at Cooper - Voorhees Recruiting
Voorhees, New Jersey, United States, 08043
Contact: Clinical Trials Office - Cancer Institute of New Jersey at Coo    856-325-6757      
United States, New York
Nalitt Cancer Institute at Staten Island University Hospital Recruiting
Staten Island, New York, United States, 10305
Contact: Frank J. Forte, MD    718-226-6400      
United States, North Carolina
Leo W. Jenkins Cancer Center at ECU Medical School Recruiting
Greenville, North Carolina, United States, 27834
Contact: Clinical Trials Office - Leo W. Jenkins Cancer Center at ECU M    252-744-2391      
United States, North Dakota
CCOP - MeritCare Hospital Recruiting
Fargo, North Dakota, United States, 58122
Contact: Preston D. Steen, MD    701-234-2397      
United States, Ohio
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center Recruiting
Columbus, Ohio, United States, 43210-1240
Contact: Ohio State University Cancer Clinical Trial Matching Service    866-627-7616    Jamesline@osumc.edu   
United States, Tennessee
Cookeville Regional Medical Center Recruiting
Cookeville, Tennessee, United States, 38501
Contact: Venumadhav R. Kotla    931-528-2541      
United States, Texas
M. D. Anderson Cancer Center at University of Texas Recruiting
Houston, Texas, United States, 77030-4009
Contact: Clinical Trials Office - M. D. Anderson Cancer Center at the U    713-792-3245      
Doctor's Hospital of Laredo Recruiting
Laredo, Texas, United States, 78045
Contact: Gary W. Unzeitig, MD    956-726-3691      
United States, Virginia
Kaiser Permanente Medical Center - Fair Oaks Recruiting
Fairfax, Virginia, United States, 22033
Contact: Amadea Tette    703-934-5700      
Kaiser Permanente Tysons Corner Medical Center Recruiting
McLean, Virginia, United States, 22102
Contact: Amadea Tette    703-287-6400      
Sponsors and Collaborators
Cancer and Leukemia Group B
Investigators
Study Chair: Electra D. Paskett, PhD Ohio State University Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00376597     History of Changes
Other Study ID Numbers: CDR0000494652, CALGB-70305
Study First Received: September 13, 2006
Last Updated: December 19, 2012
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
lymphedema
perioperative/postoperative complications
stage IA breast cancer
stage IB breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer

Additional relevant MeSH terms:
Lymphedema
Postoperative Complications
Breast Neoplasms
Lymphatic Diseases
Pathologic Processes
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 22, 2014