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

Basic Trial Information

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

Electra D. Paskett

Study Chair

U.S.A.
California
	Castro Valley
	East Bay Radiation Oncology Center
		James H. Feusner	Ph: 510-450-7600
	Valley Medical Oncology Consultants - Castro Valley
		James H. Feusner	Ph: 510-450-7600
	Concord
	Cancer Care Center at John Muir Health - Concord Campus
		Deborah L. Kerlin	Ph: 925-674-2580
	Fremont
	Valley Medical Oncology
		James H. Feusner	Ph: 510-450-7600
	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
	Tom K Lee, Incorporated
		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
Delaware
	Lewes
	Tunnell Cancer Center at Beebe Medical Center
		Stephen Scott Grubbs	Ph: 302-733-6227
	Newark
	Helen F. Graham Cancer Center at Christiana Hospital
		Stephen Scott Grubbs	Ph: 302-733-6227
District of Columbia
	Washington
	Kaiser Permanente at Capitol Hill Medical Center
		Amadea Tette	Ph: 888-823-5923
			Email: ctsucontact@westat.com
Florida
	Deerfield Beach
	North Broward Medical Center
		Douglas E Faig	Ph: 954-941-8300
	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
	Tallahassee
	Tallahassee Memorial Hospital
		Shelby L Blank	Ph: 850-431-5566
			Email: Theresa.Shannon@tmh.org
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
	Elk Grove Village
	Cancer Institute at Alexian Brothers
		Alkarim Tajuddin	Ph: 847-952-7164
			Email: fredianc@alexian.net
	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
		Costas L. Constantinou	Ph: 319-363-2690
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
	Elkton MD
	Union Hospital of Cecil County
		Stephen Scott Grubbs	Ph: 302-733-6227
	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
	Big Rapids
	Mecosta County Medical 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
New Jersey
	Camden
	Cancer Institute of New Jersey at Cooper University Hospital - Camden
		Stephen Scott Grubbs	Ph: 302-733-6227
	Elizabeth
	Trinitas Comprehensive Cancer Center at Trinitas Hospital
		Clarissa F Henson	Ph: 908-994-8000
North Carolina
	Goldsboro
	Wayne Memorial Hospital, Incorporated
		James N. Atkins	Ph: 919-580-0000
	Greenville
	Leo W. Jenkins Cancer Center at ECU Medical School
		Rachel E Raab	Ph: 252-744-2161
North Dakota
	Fargo
	Roger Maris Cancer Center at MeritCare Hospital
		Preston D. Steen	Ph: 701-234-6161
Ohio
	Columbus
	Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
		Lisa D Yee	Ph: 866-627-7616
			Email: osu@emergingmed.com
Pennsylvania
	Dubois
	Oncology Hematology Associates of Northern Pennsylvania, PC at Hahne Regional Cancer Center
		Carmine Marchioli	Ph: 570-342-3675ext218
Tennessee
	Cookeville
	Cookeville Regional Medical Center
		Venumadhav R Kotla	Ph: 931-783-2714
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
		Jamie L Wagner	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
Information obtained from ClinicalTrials.gov on April 04, 2013