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

Phase Type Status Age Sponsor Protocol IDs No phase specified Educational/Counseling/Training, Treatment Active 18 and over NCI CALGB-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 reduces 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 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

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
	Fremont
	Valley Medical Oncology
		James Feusner, MD	Ph:  510-428-3689
	Martinez
	Contra Costa Regional Medical Center
		James Feusner, MD	Ph:  510-428-3689
	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
	Pleasanton
	Valley Care Medical Center
		James Feusner, MD	Ph:  510-428-3689
	Valley Medical Oncology Consultants - Pleasanton
		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
	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
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
		Marianne Lange, MD	Ph:  616-977-6243
	Big Rapids
	Mecosta County Medical Center
		Marianne Lange, MD	Ph:  616-977-6243
	Grand Rapids
	Butterworth Hospital at Spectrum Health
		Marianne Lange, MD	Ph:  616-977-6243
	CCOP - Grand Rapids
		Marianne Lange, MD	Ph:  616-977-6243
	Lacks Cancer Center at Saint Mary's Health Care
		Marianne Lange, MD	Ph:  616-977-6243
	Holland
	Holland Community Hospital
		Marianne Lange, MD	Ph:  616-977-6243
	Muskegon
	Hackley Hospital
		Marianne Lange, MD	Ph:  616-977-6243
	Traverse City
	Munson Medical Center
		Marianne Lange, MD	Ph:  616-977-6243
	Wyoming
	Metro Health Hospital
		Marianne Lange, MD	Ph:  616-977-6243
Missouri
	Columbia
	Ellis Fischel Cancer Center at University of Missouri - Columbia
		Clinical Trial Office - Ellis Fischel Cancer Center	Ph:  573-882-4894
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
	Pinehurst
	FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center
		Clinical Trials Office - FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center	Ph:  910-715-2200
	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
		Clinical Trials Office - OSU Comprehensive Cancer Center	Ph:  614-293-4976
			Email: osu@emergingmed.com
South Carolina
	Greenville
	CCOP - Greenville
		Jeffrey Giguere, MD, FACP	Ph:  864-987-7000
Vermont
	Burlington
	Fletcher Allen Health Care - University Health Center Campus
		Clinical Trials Office - Fletcher Allen Health Care	Ph:  802-656-8990
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		2009-01-24
NCI Grant/Contract Number		CA77658