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

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, and range of motion.

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
  • 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

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

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

Outcomes

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

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, receive a refrigerator magnet, and 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

U.S.A.
California
	Castro Valley
	East Bay Radiation Oncology 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
	Glendale
	Glendale Memorial Hospital Comprehensive Cancer Center
		Clinical Trials Office - Glendale Memorial Hospital Comprehensive Cancer Center	Ph:  818-409-7653
	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
	Larry G Strieff MD Medical Corporation
		James Feusner, MD	Ph:  510-428-3689
	Tom K Lee, Incorporated
		James Feusner, MD	Ph:  510-428-3689
	Walnut Creek
	John Muir/Mt. Diablo Comprehensive Cancer Center
		Clinical Trials Office - John Muir/Mt. Diablo Comprehensive Cancer Center	Ph:  925-941-4246
Connecticut
	Bridgeport
	St. Vincent's Medical Center
		Anthy Demestihas	Ph:  203-576-6000
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:  302-623-4450
District of Columbia
	Washington
	Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
		Clinical Trials Office - Lombardi Comprehensive Cancer Center	Ph:  202-444-0381
Florida
	Jupiter
	Ella Milbank Foshay Cancer Center at Jupiter Medical Center
		Clinical Trials Office - Ella Milbank Foshay Cancer Center	Ph:  561-745-5768
	Miami Beach
	CCOP - Mount Sinai Medical Center
		Michael Schwartz, MD	Ph:  305-535-3310
	Pensacola
	Sacred Heart Cancer Center at Sacred Heart Hospital
		Clinical Trials Office - Sacred Heart Cancer Center	Ph:  850-416-4611
	Tallahassee
	Tallahassee Memorial Hospital
		Shelby Blank	Ph:  850-431-1155
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
	Elk Grove Village
	Alexian Brothers Radiation Oncology
		Alkarim Tajuddin	Ph:  847-981-5760
	Harvey
	Ingalls Cancer Care Center at Ingalls Memorial Hospital
		Clinical Trials Office - Ingalls Cancer Care Center at Ingalls Memorial Hospital	Ph:  708-915-4673
	Moline
		Costas Constantinou, MD	Ph:  563-359-9876
	Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
		Costas Constantinou, MD	Ph:  563-359-9876
Indiana
	La Porte
	Center for Cancer Therapy at LaPorte Hospital and Health Services
		Rafat Ansari, MD, FACP	Ph:  574-234-5123
	Mishawaka
	Saint Joseph Regional Medical Center
		Rafat Ansari, MD, FACP	Ph:  574-234-5123
	South Bend
	Memorial Hospital of South Bend
		Clinical Trials Office - Memorial Hospital of South Bend	Ph:  800-284-7370
Iowa
	Bettendorf
		Costas Constantinou, MD	Ph:  563-359-9876
Kansas
	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
	Cancer Center of Kansas, PA - Liberal
		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
Kentucky
	Lexington
	Central Baptist Hospital
		Clinical Trials Office - Central Baptist Hospital	Ph:  859-260-6425
Maine
	York
	York Hospital's Oncology Treatment Center
		Jonathan Eneman	Ph:  207-351-3777
Maryland
	Elkton MD
	Union Hospital of Cecil County
		Stephen Grubbs, MD	Ph:  302-366-1200
	Silver Spring
	Holy Cross Hospital
		Clinical Trials Office - Holy Cross Hospital	Ph:  310-754-7552
Massachusetts
	Boston
	Tufts Medical Center Cancer Center
		Janice Rothschild	Ph:  617-636-6100
	Hyannis
	Cape Cod Hospital
		Kelly Swanson	Ph:  508-771-1800
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
	Elizabeth
	Trinitas Comprehensive Cancer Center at Trinitas Hospital
		Clarissa Henson	Ph:  908-994-5000
	Freehold
	CentraState Medical Center
		Jarrod Kaufman	Ph:  732-431-2000
	Pomona
	AtlantiCare Cancer Care Institute at AtlantiCare Regional Medical Center - Mainland Campus
		Julianne Childs, DO, FACOI	Ph:  609-390-7888
	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
New York
	Staten Island
	Nalitt Cancer Institute at Staten Island University Hospital
		Frank Forte, MD	Ph:  718-226-6400
North Carolina
	Goldsboro
	Wayne Memorial Hospital, Incorporated
		James Atkins, MD	Ph:  919-580-0000
North Dakota
	Fargo
	CCOP - MeritCare Hospital
		Preston Steen, MD	Ph:  701-234-2397
Ohio
	Columbus
	Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
		Ohio State University Cancer Clinical Trial Matching Service	Ph:  866-627-7616
			Email: osu@emergingmed.com
South Dakota
	Sioux Falls
	Sanford Cancer Center at Sanford USD Medical Center
		Clinical Trials Office - Sanford Cancer Center	Ph:  605-328-1367
Tennessee
	Cookeville
	Cookeville Regional Medical Center
		Venumadhav Kotla	Ph:  931-528-2541
Texas
	Laredo
	Doctor's Hospital of Laredo
		Gary Unzeitig, MD	Ph:  956-726-3691
West Virginia
	Huntington
	St. Mary's Regional Cancer Center at St. Mary's Medical Center
		James Morgan, III	Ph:  304-526-1856

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		2012-02-13
NCI Grant/Contract Number		CA77658

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