Summary

for females ages 18 years and up (full criteria)
at San Francisco, California
study started
estimated completion:
Betty Smoot

Description

Summary

This study will be a 4 to 6 week randomized, controlled, assessor blinded, trial comparing a negative pressure massage device (intervention group), to the standard manual lymph drainage massage (control group), in breast cancer patients with chronic upper extremity lymphedema.

Official Title

Treatment of Breast Cancer-related Lymphedema With a Negative Pressure Device: A Feasibility Study

Details

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.

Keywords

Lymphedema, Secondary Lymphedema of Upper Limb Lymphedema Breast Cancer Lymphedema PhysioTouch Manual Lymph Drainage (MLD) Negative Pressure Manual Lymph Drainage

Eligibility

You can join if…

Open to females ages 18 years and up

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

You CAN'T join if...

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

Location

  • University of California San Francisco accepting new patients
    San Francisco California 94158 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT03252145
Lead Scientist
Betty Smoot
Study Type
Interventional
Last Updated