Trial Information

Identification of a Screening Tool and Treatment of Lymphedema Secondary to the Management of Breast Cancer Study

Background: Lymphedema has varied definitions, all based on limb volume changes. None
incorporates limb volume changes, symptoms, and functional deficits. We will determine the
incidence of lymphedema in breast cancer patients and the impact of breast conserving
therapy, radiation therapy, sentinel lymph node biopsy, and axillary node dissection. The
impact of lymphedema can be evaluated in a number of ways; 1) The Lymphedema and Breast
Cancer Questionnaire (LBCQ) identifies symptoms that are unique to patients with lymphedema
and 2) The Disability of the Arm, Hand, and Shoulder (DASH) survey will be used to determine
the functional impact of lymphedema.

Objective/Hypothesis: Our hypotheses are: 1) Local therapies for breast cancer result in
different lymphedema rates depending on the combination of therapies used. 2) A simple
screening tool that incorporates symptoms, limb volume measurements, and tumor staging and
treatment modalities can predict those patients that will develop lymphedema. 3) Functional
impairment of the arm is severe in patients with lymphedema. 4) Prevention of lymphedema in
a high risk population is possible with education, a compression sleeve, and decongestive
exercise.

Specific Aims: 1) Evaluate patients both pre-operatively and at specific time intervals
post-operatively to establish the incidence of lymphedema in sentinel lymph node biopsy and
axillary dissection groups. 2) Create a simple screening tool using arm measurements,
symptoms identified by the LBCQ, and treatment and staging information to identify patients
that should go on to further testing and treatment. 3) Utilize the DASH survey to measure
the extent of disability from lymphedema and surgical treatment. 4) Conduct a randomized
trial of lymphedema prevention in a high-risk breast cancer population.

Study Design: This proposal will be conducted in two phases. Phase 1 will accomplish
Specific Aim 1, 2, and 3. Patients with newly diagnosed breast cancer awaiting definitive
surgery, will be enrolled pre-operatively and undergo arm measurements and complete the LBCQ
and the DASH surveys. These same study procedures will be completed at 1, 3, 6, 12, 18, and
24 months postoperative. Documentation collected during the study will include: demographic
information; co-morbid conditions; operative and pathology reports; and use of adjuvant
therapies such as chemotherapy, hormonal therapy, and radiation therapy. Incidence rates of
lymphedema and the impact of extent of surgery and radiation therapy will be determined. We
will also use this information to develop a simple screening tool to identify patients that
will develop lymphedema prior to the development of significant limb volume changes.
Specific Aim 4 is Phase 2 of the proposal. A high risk population (those that have an
axillary node dissection and radiation therapy) will be randomized to standard education
versus standard education, compression sleeve, and exercise. The effectiveness of
prevention to reduce incidence and severity of lymphedema and the impact on symptoms and
functional impairment will be determined. This work will move toward a new paradigm of
lymphedema management with a simple screening tool to identify high risk patients before
significant swelling occurs and investigate prevention strategies to decrease the incidence
of lymphedema.

Cancer Relevance: Lymphedema is a feared complication of breast cancer treatment.
Currently it is recognized and treated only after development of significant limb volume
changes when it is symptomatic and difficult to treat. Documentation of the impact of local
therapies on the development of lymphedema will allow clinicians to make more informed
decisions regarding risk benefit ratios of each of our local therapies. Development of a
screening tool will allow us to identify high risk populations. Ideally, the high risk
population will be identified and an effective prevention strategy implemented. Phase one
of this study will help to answer the questions regarding incidence and create a screening
tool and phase two will allow the evaluation of a prevention strategy.