Breast Cancer Clinical Trial

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

Summary

This randomized phase III trial studies how well education with or without physical therapy intervention works in preventing lymphedema in women with stage I, II, or III breast cancer who are undergoing axillary lymph node dissection (surgery to remove lymph nodes found in the armpit region). Lymphedema is a condition in which extra lymph fluid builds up in tissues and causes swelling in an arm or leg if lymph vessels are blocked, damaged, or removed by surgery. A personalized physical therapy intervention and education materials may be better than education materials alone in preventing lymphedema in women with breast cancer who are undergoing axillary lymph node dissection.

View Full Description

Full Description

OBJECTIVES:

I. To test, in a group randomized controlled trial, the efficacy of this program versus education only in reducing the incidence of lymphedema.

II. To compare the severity of lymphedema, in terms of changes in arm circumference at the site of greatest difference as a continuous variable between the two interventions.

III. To assess the agreement between patients' self-report of swelling (mild, moderate, and severe) and the extent of circumferential measurement difference between the treated side and the contralateral arm at the site of greatest difference.

IV. To compare the health-related quality of life (Factional Assessment of Cancer Therapy-Breast [FACT-B]+4 score) between the two interventions.

V. To characterize adherence to lymphedema prevention exercises, lymphedema knowledge, and range of motion.

OUTLINE: Patients are randomized to 1 of 2 arms.

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 physical therapy intervention, receive a refrigerator magnet, and a 15-minute video that reinforces information and exercises.

View Eligibility Criteria

Eligibility Criteria

Eligibility Criteria:

Newly diagnosed with stage I-III cancer of the female breast

No prior history of carcinoma in situ, lobular carcinoma in situ (LCIS), ductal carcinoma in situ (DCIS), 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 cancer of the skin are eligible

Neoadjuvant therapy

Patients scheduled to receive any type of radiation therapy to the breast or axilla are eligible; however, they must be registered to this study with pre-surgery measures taken prior to receiving neoadjuvant therapy
Patients scheduled to receive neoadjuvant chemotherapy are also eligible; however, they must be registered to this study with pre-surgery measurements taken prior to receiving neoadjuvant therapy
Patients receiving no neoadjuvant therapy are eligible
May be enrolled on other treatment trials; however, patients enrolled on surgery trials where only one treatment arm is full axillary node dissection are not eligible; NOTE: Patients enrolled on American College of Surgeons Oncology Group (ACOSOG)-Z1071 are eligible to participate in this study; patients concurrently enrolled on this study and ACOSOG-Z1071, may not also be enrolled on the ACOSOG-Z1071 lymphedema sub-study
No documented cardiac conduction disturbances, unstable angina, dementia, or any other chronic disease which, in the opinion of the treating physician, significantly increases mortality over the next 2 years
No diagnosed lymphedema
In order to be properly fitted for the elastic sleeve, eligible patients must have arm measurements for axilla, elbow, and wrist that fall within the ranges for one of the six sleeve sizes
Not currently homebound or dependent upon a walker or wheelchair for mobility
Able to participate in a mild exercise program
Willing to return to the study site for the duration of the study (18 months)
Sentinel (SND) or full axillary node dissection (AND) (no minimum number of nodes required)
Patients with double mastectomy, axillary node dissection and/or radiation on both arms are ineligible; patients who undergo these treatments (i.e., surgery and/or radiation) on the contralateral arm after registration to Step 2 are still eligible to remain in the study; however, it should be documented appropriately on form C-1628 at the conclusion of study participation

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

568

Study ID:

NCT00376597

Recruitment Status:

Completed

Sponsor:

Alliance for Clinical Trials in Oncology

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There are 65 Locations for this study

See Locations Near You

East Bay Radiation Oncology Center
Castro Valley California, 94546, United States
Valley Medical Oncology Consultants - Castro Valley
Castro Valley California, 94546, United States
Cancer Care Center at John Muir Health - Concord Campus
Concord California, 94524, United States
Valley Medical Oncology
Fremont California, 94538, United States
Contra Costa Regional Medical Center
Martinez California, 94553, United States
El Camino Hospital Cancer Center
Mountain View California, 94040, United States
Highland General Hospital
Oakland California, 94602, United States
Alta Bates Summit Medical Center - Summit Campus
Oakland California, 94609, United States
Bay Area Breast Surgeons, Incorporated
Oakland California, 94609, United States
CCOP - Bay Area Tumor Institute
Oakland California, 94609, United States
Larry G Strieff MD Medical Corporation
Oakland California, 94609, United States
Tom K Lee, Incorporated
Oakland California, 94609, United States
Doctors Medical Center - San Pablo Campus
San Pablo California, 94806, United States
John Muir/Mt. Diablo Comprehensive Cancer Center
Walnut Creek California, 94598, United States
St. Vincent's Medical Center
Bridgeport Connecticut, 06606, United States
Tunnell Cancer Center at Beebe Medical Center
Lewes Delaware, 19958, United States
CCOP - Christiana Care Health Services
Newark Delaware, 19713, United States
Kaiser Permanente at Capitol Hill Medical Center
Washington District of Columbia, 20002, United States
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
Washington District of Columbia, 20007, United States
North Broward Medical Center
Deerfield Beach Florida, 33064, United States
Ella Milbank Foshay Cancer Center at Jupiter Medical Center
Jupiter Florida, 33458, United States
CCOP - Mount Sinai Medical Center
Miami Beach Florida, 33140, United States
Sacred Heart Cancer Center at Sacred Heart Hospital
Pensacola Florida, 32504, United States
Tallahassee Memorial Hospital
Tallahassee Florida, 32308, United States
Resurrection Medical Center
Chicago Illinois, 60631, United States
University of Chicago Cancer Research Center
Chicago Illinois, 60637, United States
Alexian Brothers Radiation Oncology
Elk Grove Village Illinois, 60007, United States
Ingalls Cancer Care Center at Ingalls Memorial Hospital
Harvey Illinois, 60426, United States
Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
Moline Illinois, 61265, United States

Moline Illinois, 61265, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte Indiana, 46350, United States
Saint Joseph Regional Medical Center
Mishawaka Indiana, 46545, United States
CCOP - Northern Indiana CR Consortium
South Bend Indiana, 46601, United States
Memorial Hospital of South Bend
South Bend Indiana, 46601, United States
Michiana Hematology-Oncology, PC - South Bend
South Bend Indiana, 46601, United States

Bettendorf Iowa, 52722, United States
Cancer Center of Kansas, PA - Chanute
Chanute Kansas, 66720, United States
Cancer Center of Kansas, PA - Dodge City
Dodge City Kansas, 67801, United States
Cancer Center of Kansas, PA - El Dorado
El Dorado Kansas, 67042, United States
Cancer Center of Kansas - Fort Scott
Fort Scott Kansas, 66701, United States
Cancer Center of Kansas-Independence
Independence Kansas, 67301, United States
Cancer Center of Kansas, PA - Kingman
Kingman Kansas, 67068, United States
Lawrence Memorial Hospital
Lawrence Kansas, 66044, United States
Cancer Center of Kansas, PA - Liberal
Liberal Kansas, 67901, United States
Cancer Center of Kansas, PA - McPherson
McPherson Kansas, 67460, United States
Cancer Center of Kansas, PA - Newton
Newton Kansas, 67114, United States
Cancer Center of Kansas, PA - Parsons
Parsons Kansas, 67357, United States
Cancer Center of Kansas, PA - Pratt
Pratt Kansas, 67124, United States
Cancer Center of Kansas, PA - Salina
Salina Kansas, 67401, United States
Cancer Center of Kansas, PA - Wellington
Wellington Kansas, 67152, United States
Associates in Womens Health, PA - North Review
Wichita Kansas, 67208, United States
Cancer Center of Kansas, PA - Medical Arts Tower
Wichita Kansas, 67208, United States
Cancer Center of Kansas, PA - Wichita
Wichita Kansas, 67214, United States
CCOP - Wichita
Wichita Kansas, 67214, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita Kansas, 67214, United States
Cancer Center of Kansas, PA - Winfield
Winfield Kansas, 67156, United States
Central Baptist Hospital
Lexington Kentucky, 40503, United States
York Hospital's Oncology Treatment Center
York Maine, 03909, United States
Kaiser Permanente at Woodlawn Medical Center
Baltimore Maryland, 21244, United States
Union Hospital of Cecil County
Elkton Maryland, 21921, United States
Kaiser Permanente - Gaithersburg Medical Center
Gaithersburg Maryland, 20879, United States
Kaiser Permanente Mid-Atlantic Medical Group-Largo Medical Facility
Largo Maryland, 20774, United States
Holy Cross Hospital
Silver Spring Maryland, 20910, United States
Tufts Medical Center Cancer Center
Boston Massachusetts, 02111, United States
Cape Cod Hospital
Hyannis Massachusetts, 02601, United States
Trinitas Comprehensive Cancer Center at Trinitas Hospital
Elizabeth New Jersey, 07207, United States
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees New Jersey, 08043, United States
Nalitt Cancer Institute at Staten Island University Hospital
Staten Island New York, 10305, United States
Leo W. Jenkins Cancer Center at ECU Medical School
Greenville North Carolina, 27834, United States
CCOP - MeritCare Hospital
Fargo North Dakota, 58122, United States
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
Columbus Ohio, 43210, United States
Cookeville Regional Medical Center
Cookeville Tennessee, 38501, United States
M. D. Anderson Cancer Center at University of Texas
Houston Texas, 77030, United States
Doctor's Hospital of Laredo
Laredo Texas, 78045, United States
Kaiser Permanente Medical Center - Fair Oaks
Fairfax Virginia, 22033, United States
Kaiser Permanente Tysons Corner Medical Center
McLean Virginia, 22102, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

568

Study ID:

NCT00376597

Recruitment Status:

Completed

Sponsor:


Alliance for Clinical Trials in Oncology

How clear is this clinincal trial information?

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