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

Completed · Not applicable

Conditions studied: Lymphedema, Secondary, Lymphedema of Upper Limb

In brief

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.

Key facts

Study ID

NCT03252145

Run by

University of California, San Francisco

People needed

28

Starts

2017-10-31

Expected to finish

2020-01-31

Last updated by the study team

2021-01-15

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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 L-Dex® 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 University of California, San Francisco (UCSF) Parnassus campus;
• Read and understand English;
• Be able to understand a written informed consent document and the willingness to sign it

You may not qualify if…

• Women cannot have:
• Bilateral upper extremity LE;
• Current infection or lymphangitis involving the affected arm;
• Current recurrence of their breast cancer (BC) (local or distant)
• Pre-existing LE prior to their BC diagnosis;
• A condition that precludes measurement of LE using Bioimpedance Spectroscopy (BIS), including pregnancy;
• Current venous thrombosis in either upper extremity or be on current anticoagulant therapy;
• Extremity edema due to heart failure

Where it is running

• University of California San Francisco — San Francisco, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.