Early Detection and Intervention for Mild and Moderate Lymphedema in Patients Treated for Breast Cancer

Status: Recruiting
Phase: Phase 3
Diagnosis: Breast: Early Stage Disease
NCT ID: NCT00959985 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 08-308


Women who have been treated for breast cancer may be at risk for lymphedema or arm swelling. Currently, there are no clear treatment guidelines for lymphedema. One treatment method used to treat lymphedema is the use of compression sleeves to encourage the flow of lymph fluid out of the arms and prevent arm swelling in the future. Another treatment method is more intensive and involves wearing compression sleeves as well as special compression bandages overnight. It is unclear whether the use of compression with both sleeves and bandaging is more effective in treating lymphedema than the use of compression sleeves alone. The purpose of this research study is to evaluate the effectiveness of the use of compression garments in preventing or slowing the progression of lymphedema in breast cancer patients.


Conducting Institutions:
Massachusetts General Hospital

Overall PI:
Alphonse Taghian, MD, PhD, Massachusetts General Hospital

Site-responsible Investigators:

Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100

Eligibility Criteria

Inclusion Criteria: - Participants must have histologically or cytologically confirmed invasive or in-situ carcinoma of the breast - Participants must have undergone sentinel lnode mapping or axillary dissection - Participants must have had a pre-operative Perometer measurement, and consecutive measurement at 4-6 month intervals prior to the onset of low volume edema (>5% from baseline) - Age > 18 years - Life expectancy of greater than 1 year - Participants must have a Perometer measurement of 5% or greater volume difference (RVC) to qualify for randomization - Ability to understand and willingness to sign a written informed consent document - Willingness to comply with required follow up Perometer measurements and clinical visits Exclusion Criteria: - Known metastatic disease or other locally advanced disease in the thoracic or cervical regions - Any patient who will not be returning routinely for follow-up - Known brain metastases will be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events - History of primary lymphedema - History of prior surgery or radiation to the head, neck, upper limb, or trunk - Evidence that axillary lymph node malignancy is causing lymphedema due to recurrence as per physician discretion - Any patient who has bilateral lymph node mapping or dissection - Any patient with a current case of cellulitis - Patients with a history of a different malignancy are ineligible except for the following circumstances. Individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancer are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin
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