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Summary

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

Description

Summary

This study will be a 4-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-week, single group, pilot feasibility study will enroll 40 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.

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.

Keywords

Lymphedema, Secondary Lymphedema of Upper Limb Lymphedema Breast Cancer Lymphedema

Eligibility

You can join if…

Open to females ages 18 years and up

  • adult women >18 years of age
  • have completed active treatment for breast cancer one year previously but not longer than 20 years ago
  • cancer treatment included a surgical procedure, radiation therapy (RT), and/or chemotherapy (CTX)
  • at least 1 year since diagnosis of lymphedema
  • confirmed lymphedema diagnosis at study enrollment
  • Lymphedema must be stable: "stable" if during the 3 months prior to study enrollment there was no therapist-delivered LE treatment, no arm infection requiring antibiotics,no change in ability to perform activities of daily living related to LE, and no subjective report of persistent changes in limb volume.
  • pre and postmenopausal women will be included
  • mentally and physically able to participate in the study
  • Ability to understand a written informed consent document and the willingness to sign it

You CAN'T join if...

  • have a current infection or lymphangitis involving the affected arm
  • have neuromuscular conditions that would affect upper limb function
  • have experienced recurrence of their breast cancer (local or distant)
  • had pre-existing lymphedema prior to their breast cancer diagnosis
  • have a condition that precludes measurement of LE using bioimpedance spectroscopy(BIS), including pregnancy
  • bilateral breast cancer treatment
  • bilateral upper extremity lymphedema
  • any history of venous thrombosis in either upper extremity
  • extremity edema due to heart failure
  • inability to attend sessions at the UCSF School of Nursing for the study duration

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
October 28, 2017
I’m interested in this study!