Identification of a Screening Tool and Treatment of Lymphedema Secondary to the Management of Breast Cancer Study
Stopped early · Not applicable
Conditions studied: Breast Cancer, Lymphedema
In brief
The proposed research is designed to establish lymphedema incidence rates for a varied population of breast cancer patients. Patients with breast preservation, mastectomy, sentinel lymph node biopsy, axillary dissection and radiation therapy will be included with the goal of determining the impact that each of these treatments has on development of lymphedema. Establishing incidence in these populations is crucial to the remainder of the study. We conduct a two phase study. The first phase will use arm measurements, a symptom survey (The Lymphedema and Breast Questionnaire), a functional survey (Disability of the Arm, Shoulder, and Hand Questionnaire), and operative and pathology information to create a simple screening tool to predict the development of lymphedema. Currently, lymphedema is only diagnosed after arm swelling develops. The goal of the screening tool is to identify those patients at significantly increased risk for development of lymphedema as compared to the general population of breast cancer survivors. Phase 2 of the study will test a lymphedema prevention strategy in a high risk population. The goal of this phase is to reduce the incidence of lymphedema in those patients that have undergone an axillary node dissection with radiation therapy by using a combination of education, a compression sleeve and decongestive exercises. If prevention is successful, the development of a screening tool becomes even more important to identify those patients that should undergo a prevention regimen.
Key facts
- Study ID
- NCT00282529
- Run by
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- People needed
- 400
- Starts
- 2006-01-01
- Expected to finish
- 2007-11-01
- Last updated by the study team
- 2017-01-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age of 18 years or older, biopsy proven breast cancer with no known metastatic cancer, surgical management of breast cancer with node evaluation to be completed at Johns Hopkins Hospital, ability to speak and read English, willing and able to continue follow-up at Johns Hopkins Avon foundation Breast Center -
- Exclusion Criteria: Known psychiatric illness, unwillingness to be followed for two years, functional arm deficits, prior radiation therapy to the breast or axilla, any prior diagnosis of cancer except basal cell cancer
Where it is running
- Avon Breasts Center, Johns Hopkins Medical Institutions — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
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