Status:
TERMINATED
Early Detection and Intervention for Mild and Moderate Lymphedema in Patients Treated for Breast Cancer
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lymphedema
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
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 lymph...
Detailed Description
* Because no one knows which of the study options is best, participant's will be randomized into one of the study groups. Participants with mild lymphedema will be randomized into either Group 1A or G...
Eligibility Criteria
Inclusion
- Participants must have histologically or cytologically confirmed invasive or in-situ carcinoma of the breast
- Participants must have undergone sentinel lymph node 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
- 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
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00959985
Start Date
August 1 2009
End Date
August 1 2014
Last Update
May 30 2017
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114