Treatment of Breast Cancer-related Lymphedema With a Negative Pressure Device

Lymphedema (LE) is a protein-rich interstitial swelling caused by reduced lymph transport
secondary to lymphatic system damage from cancer treatments. 1 in 5 women will develop LE
following breast cancer treatment. These women have greater restrictions in activity and
poorer quality of life (QOL) and are more prone to cellulitis than women without LE. LE is
incurable and progressive. Persistent lymph stasis creates a condition of chronic
inflammation that contributes to fibrosis and fatty deposition in the subcutis of the
affected limb. The fibro-adipose changes associated with chronic LE make it less responsive
to treatments that primarily target limb volume. Treatments are needed that can improve these
skin and subcutaneous tissues changes, as well as reduce limb volume.

This 4 to 6 week randomized controlled pilot feasibility study will enroll 80 women with
chronic arm LE, and will evaluate a novel negative pressure massage device that mobilizes
skin and subcutaneous tissue. This negative pressure treatment provides vertical (lifting)
and horizontal stretching of the skin and underlying fascial structures, which increases the
subcutaneous space for lymphatic circulation, improves lymph flow, and has the potential to
decrease fibrosis. This treatment will be compared to the standard of care massage: manual
lymphatic drainage. Women will be randomly assigned to either the negative pressure massage
device (intervention group), to the standard manual lymph drainage massage (control group)

Objectives: To evaluate recruitment and retention rates; to determine rates of adverse
events; and to determine effect sizes for limb volume, tissue induration; and patient
reported outcomes of arm function, QOL, and body image in response to treatment

An additional exploratory aim of the study is to evaluate for changes in circulating
biomarkers of inflammation and fibrosis following treatment.

INCLUSION CRITERIA:

To be included women must be:

Be over 18 years of age;

Have had cancer treatment that included a surgical procedure, radiation therapy (RT),
and/or chemotherapy (CTX);

Have completed active cancer treatment at least 1 year prior to study enrollment;

Have been diagnosed with lymphedema (LE) at least one year prior to study enrollment;

Have arm lymphedema on one side only;

Have confirmed LE based on bioimpedance measurements with an LDex score of >7.1 (note -
this is very mild lymphedema);

Have stable arm LE. LE will be considered "stable" if during the 3 months prior to study
enrollment there was no arm infection requiring antibiotics, no change in ability to
perform activities of daily living related to LE, and no subjective report of significant
persistent changes in limb volume;

Be mentally and physically able to participate in the study;

Be able to attend the sessions at the UCSF Parnassus campus;

Read and understand English;

Be able to understand a written informed consent document and the willingness to sign it

EXCLUSION CRITERIA

Women cannot have:

Bilateral upper extremity LE;

Current infection or lymphangitis involving the affected arm;

Current recurrence of their BC (local or distant)

Pre-existing LE prior to their BC diagnosis;

A condition that precludes measurement of LE using BIS, including pregnancy;

Current venous thrombosis in either upper extremity or be on current anticoagulant therapy;

Extremity edema due to heart failure