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

Lymphedema of Upper Limb Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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 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 ;

Related Conditions & MeSH terms

• Breast Cancer Lymphedema
• Lymphedema
• Lymphedema of Upper Limb
• Lymphedema, Secondary

• NCT number: NCT03252145
• Study type: Interventional
• Source: University of California, San Francisco
• Status: Completed
• Phase: N/A
• Start date: October 31, 2017
• Completion date: January 31, 2020