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

University of California San Francisco (UCSF)

Status: Completed

Conditions: Lymphedema of Upper Limb; Lymphedema, Secondary

Treatments: Device: PhysioTouch; Other: Manual Lymph Drainage (MLD)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03252145

16802

NCI-2018-00009 (Registry Identifier)

P0518095

Details and patient eligibility

About

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.

Full 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

Enrollment: 28 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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28 participants in 2 patient groups

Negative Pressure

Experimental group

Description:

PhysioTouch (negative pressure massage) treatment 3 times a week for 4 weeks to the lymphedematous upper limb

Treatment:

Device: PhysioTouch

Manual Lymph Drainage

Active Comparator group

Description:

Manual lymph drainage (MLD) treatment 3 times a week for 4 weeks to the lymphedematous upper limb

Treatment:

Other: Manual Lymph Drainage (MLD)