Prospective Analysis of Symptoms and Lymphedema in Patients Following Treatment for Breast Cancer



Status:Recruiting
Conditions:Breast Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:August 2009

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Prospective Analysis of Symptoms, Functionality and Quality of Life Questionnaires to Evaluate Lymphedema in Patients Following Treatment for Breast Cancer.

The objective of this study is to determine the level of symptoms, functional disability,
and changes in quality of life that breast cancer patients experience from changes in their
arm(s) during and after treatment for breast cancer. These problems are often associated
with transient or chronic lymphedema, numbness, reduced shoulder flexibility, and an altered
ability to use the arm for functional activities of daily living. The goal of this study is
to collect data to support the hypothesis that swelling and other impairments in the upper
extremities, causes a significant level of symptoms, functional disability and diminished
quality of life for patients. Furthermore the investigators hope to evaluate how symptoms in
the upper extremity (such as decreased functionality, sensory changes, pain or stiffness)
are related to early, low volume lymphedema.

The method that we propose for this trial is to administer a condensed form of the
Lymphedema and Breast Cancer Questionnaire (LBCQ) , Disabilities of the Arm Shoulder and
Hand (DASH) and Functional Assessment of Cancer Therapy- Breast quality of life instrument
(FACT-B) as surveys/questionnaires within the clinic. This combined questionnaire is called
the lymphedema evaluation following treatment for breast cancer (LEFT-BC). All patients who
present for a baseline (pre-operative) arm measurement will be offered the opportunity to
participate in this trial. At that point the purpose of the trial will be explained. Any
patient that wishes to participate will be provided the questionnaires to complete and
return (by mail or in person) to the study coordinator prior to surgery. During follow-up
visits, questionnaires will be collected prior to perometer measurements and will be
analyzed in conjunction with the measurements taken on the same day. We will utilize the
questionnaires to evaluate their symptoms, functionality and quality of life (QOL). The
perometer is a well-validated instrument and considered the gold standard today for
quantifying volume in a limb. It is accurate to within a percent and far more accurate than
circumferential measurement using a tape measure. It has been a regular part of the standard
of care for MGH breast cancer patients. Patients are routinely measured at diagnosis, after
surgery, after chemotherapy, after radiation, at four to six-month follow-up visits that
continue for years, and anytime a patient reports with new symptoms of swelling or arm
discomfort outside of these time frames.

Inclusion Criteria:

- Confirmed diagnosis of breast cancer

- No metastatic disease in the cervical or thoracic regions

- No bulky disease in the thoracic or cervical region

- No history of primary Lymphedema

- No prior surgery to the head, neck, upper limb or trunk

- No prior radiation to the head, neck, upper limb or trunk

- No evidence of axillary lymph node malignancy causing Lymphedema due to recurrence

Exclusion Criteria:

- metastatic or other locally advanced disease in the cervical or thoracic regions

- known brain metastases

- history of primary Lymphedema

- history of prior surgery or radiation to the head, neck, upper limb or trunk

- axillary lymph node malignancy causing Lymphedema (per physician discretion)

- current case of cellulitis

- history of a different malignancy except for the following: History of other
malignancies if they are disease-free for 5+ years and deemed by the PI to be at low
risk for recurrence OR <5 years of diagnosis and treatment for cervical cancer in
situ, basal or squamous cell carcinoma of the skin.

- Will not be returning routinely for follow-up at MGH or DFHCC
We found this trial at
1
site
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Alphonse G Taghian, MD PhD
Phone: 617-726-6050
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mi
from
Boston, MA
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