Trial Information

Evaluation of Non Invasive Imaging for Assessing the Pathophysiology of Cording in Patients Treated for Breast Cancer

Cords are bands of tissue that are present in the axilla following breast cancer surgery and
may extend across the antecubital fossa and into the forearm. Cords are often painful to
patients and limit their shoulder range of motion.The proposed study design involves the
recruitment of patients who are enrolled in Partners Protocol # 2008P000540, a prospective
analysis of symptoms, functionality and quality of life questionnaire to evaluate lymphedema
in patients following treatment for breast cancer. This protocol recruits newly diagnosed
breast cancer patients prior to any treatment interventions. Subjects are required to
undergo volumetric arm measurements and complete the Lymphedema Evaluation Following
Treatment for Breast Cancer Questionnaire (LEFT-BC) which will allow for the evaluation of
changes in functionality, upper extremity utilization (fear associated avoidance), and
quality of life. Throughout treatment patients will be screened before and after each
treatment event: surgery, chemotherapy and radiation. Following the conclusion of treatment
for breast cancer, patients will be measured at least 2 times per year (every 4-7 months).
If during these study visits the patient notes cording symptoms, the research staff
administering the questionnaire will be alerted. At this point, they will notify a
designated medical provider who will perform a physical examination of the area to confirm
the presence of cording. Once the presence of cording is verified, the patient will be
provided with the opportunity to enroll in the proposed trial. Due to the current limited
knowledge on the nature of the condition, the patients arm and axilla will have to be imaged
within 7 days of the physical exam confirmation. The patients will be asked to return to the
vascular imaging lab located on the Massachusetts's General Hospital's main campus. They
will undergo a venous duplex ultrasound, on a General Electric LOGIQ-9 unit with a
Phillips-IU-22 probe.