Bioelectrical Impedance for Self-monitoring of Lymphedema

Breast cancer treatment-related lymphedema (swelling) is an incurable, chronic condition
experienced by a significant percentage of breast cancer survivors. It has many associated
symptoms, negatively impacts quality of life (QOL), and increases health care costs. As with
other chronic diseases, such as diabetes, life-long self-care is required. No objective
measurement mechanism exists that can easily be used to self-monitor arm volume, a key
self-care outcome. Those with lymphedema are forced to rely on visual recognition of
increasing volume to know if their self-care is effective and when to seek treatment. Timely
recognition of worsening swelling is believed to result in better patient outcomes; however,
substantial volume increases often occur before observable changes are noted and this window
of opportunity is missed. Many with lymphedema only seek care when they have developed
infection in the swollen limb.

The inability to objectively monitor arm volume on a regular basis likely results in
discomfort, poorer QOL, and increased health care costs.The broad, long-term objective of
this application is to develop a method for monitoring arm lymphedema that can be used at
home to improve lymphedema self-management and patient outcomes. To accomplish this, the
investigators will conduct a two-phase, translational pilot study to explore the use of a
hand-held bioelectrical impedance device as an arm volume self-measurement method.

The purpose of Phase 1 is to develop a bioelectrical impedance self-measurement protocol.
Healthy volunteers (n=11) and individuals with lymphedema (n=11) will be in Phase 1
(protocol development). This will take place in laboratory and home settings. This Phase is
not interventional and is not detailed in this posting.

The purpose of Phase 2 is to compare self-care activities and health and economic outcomes
between breast cancer survivors with lymphedema following the self-monitoring protocol
developed in Phase 1 and breast cancer survivors with lymphedema not on protocol (n=42).The
protocol will be field-tested by breast cancer survivors with lymphedema in Phase 2 (a two
group randomized clinical trial). One group will self-measure with impedance at home for
three months, weekly record self-care activities, and will complete follow-up assessments.
The other group will mirror Group 1 except for impedance measurements. This is an
interventional study and is presented as such in this clinical trial posting.

Inclusion Criteria:

1. Healthy Volunteers for Phase 1: no known history of cancer or lymphatic disease.

2. Lymphedema volunteers Phases 1 &2: history of breast cancer and diagnosis of
lymphedema in one arm.

3. All volunteers: ≥ 21 years of age.

Exclusion Criteria:

1. Healthy Volunteers Phase 1: history of arm surgery or family history of primary
lymphedema.

2. Lymphedema volunteers Phases 1 & 2: bilateral lymphedema.

3. All volunteers:

- inability to stand upright;

- conditions that could cause swelling: pregnancy, congestive heart failure, liver
failure;

- infection, open sores on arms, or known sensitivity to electrodes;

- pacemakers or internal defibrillators;

- currently undergoing IV chemotherapy or radiation; or

- use of laxatives or diuretics to lose weight.