Prospective Analysis of Symptoms and 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.

Newly diagnosed breast cancer patients.

• Ancukiewicz M, Miller CL, Skolny MN, O'Toole J, Warren LE, Jammallo LS, Specht MC, Taghian AG. Comparison of relative versus absolute arm size change as criteria for quantifying breast cancer-related lymphedema: the flaws in current studies and need for universal methodology. Breast Cancer Res Treat. 2012 Aug;135(1):145-52. Epub 2012 Jun 19.
• Ancukiewicz M, Russell TA, Otoole J, Specht M, Singer M, Kelada A, Murphy CD, Pogachar J, Gioioso V, Patel M, Skolny M, Smith BL, Taghian AG. Standardized method for quantification of developing lymphedema in patients treated for breast cancer. Int J Radiat Oncol Biol Phys. 2011 Apr 1;79(5):1436-43. Epub 2010 Jun 3.

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