Non-Invasive Imaging for Cording in Breast Cancer Patients

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.

Inclusion Criteria:

- Participants must be enrolled in Partners protocol # 2008P000540 "Prospective
Analysis of Symptoms, Functionality and Quality of Life Questionnaires to Evaluate
Lymphedema in Patients Following Treatment for Breast Cancer"

- Confirmed case of cording by a medical provider (Physician, Nurse Practitioner,
Physician Assistant)

- Participants must be at least 18 years of age

- Life expectancy of greater than 1 year.

- Ability to understand and the willingness to sign a written informed consent
document.

- Willingness to comply with required follow up Perometer measurements and clinical
visits.

Exclusion Criteria:

- Participants who are not enrolled or have been removed from Partners Protocol #
2008P000540 will be excluded from this trial.

- Participants with known brain metastases should 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 prior surgery or radiation to the head, neck, upper limb, or trunk.

- 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 cancers 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.