The treatment of lymphedema following breast cancer therapy is typically a burdensome
multi-modality process that entails different degrees of intensity depending on the
severity of fluid accumulation. In breast cancer survivors, it is most commonly initiated
after visible swelling occurs in a limb. Common treatments utilized are multi-modality
and include massage, compression, exercises, and skin care. The current gold standard
treatment for advanced fluid accumulation is complex decongestive physiotherapy (CDP).
CDP includes components of compression, lymphatic drainage, skin care, and exercise and
is commonly delivered in two phases with the first phase being a several week course
delivered in the outpatient clinical setting and the second a home maintenance program.
CDP is considered the gold standard due to prospective data demonstrating its efficacy, a
series of 537 patients found significant arm volume decreases with CDP and subsequent
studies have confirmed volume reductions along with improved quality of life in those
patients undergoing CDP. Studies comparing CDP to other treatment modalities are limited
but some have favored CDP. CDP is limited in that access to long term prospective
follow-up treatment may not take place and it requires significant resources and costs.
Recent studies have suggested that early diagnosis and treatment allow for less
burdensome and aggressive therapy utilization moving forward. Increasing data support the
idea that early intervention improves outcomes for women with lymphedema following breast
cancer treatment. Recent prospective data have shown that with a short course of
compression therapy (sleeve and gauntlet), ranging from 4 to 6 weeks, the rate of
progression of fluid accumulation is limited. Specifically, the Stout Gergich et al.
study provided sound preliminary data to support that four weeks of treatment using a
20-30 mmHg compression garment and gauntlet can, over 18 months of post intervention
follow-up, reduce volume and prevent the need for CDP.
These findings are encouraging; however, it should be noted that these studies have
significant limitations including small patient numbers, limited follow up, a lack of
randomization, and a lack of subclinical detection of increasing extracellular fluid.
Therefore, while some data exist that suggest that early intervention with clinically
apparent extracellular fluid accumulation is beneficial, there are less data to support
the hypothesis that subclinical detection and subsequent early intervention are
beneficial. Based on data from these studies, it may be possible to prevent chronic
lymphedema with early detection and intervention. Early detection may be best achieved by
identifying changes in extracellular fluid instead of change in whole arm volume. Given
the potential to improve patient outcomes and possibly prevent chronic lymphedema,
additional research is warranted in large randomized trials that address some of the
limitations of the previous work.
BIS is a technology designed to identify changes in extracellular fluid. The
investigators propose to determine if subclinical detection of increasing extracellular
fluid via BIS and subsequent early treatment with four weeks of a compression sleeve and
gauntlet results in a reduction in the rates of progression to chronic lymphedema as
compared to the same intervention when initiated from use of the most common arm
measurement method (tape measurement).
The investigators will secondarily explore selective correlatives related to lymphedema
and lymphedema progression. As multiple factors may lead to lymphedema, the influence of
potential risk factors on lymphedema progression will be evaluated. Time to actual
progression will also be examined. Because lymphedema results in problematic symptoms and
diminished quality of life, correlatives using validated instruments will also be
examined.
