Status:
COMPLETED
Treatment of Breast Cancer-related Lymphedema With a Negative Pressure Device
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
Foundation for Physical Therapy, Inc.
Conditions:
Lymphedema, Secondary
Lymphedema of Upper Limb
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief 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 (contr...
Detailed Description
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 can...
Eligibility Criteria
Inclusion
- 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 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
- EXCLUSION CRITERIA
- 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
Exclusion
Key Trial Info
Start Date :
October 31 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2020
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT03252145
Start Date
October 31 2017
End Date
January 31 2020
Last Update
January 15 2021
Active Locations (1)
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1
University of California San Francisco
San Francisco, California, United States, 94158