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

NCT ID: NCT03252145

Last Updated: 2021-01-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-31
• Study Completion Date: 2020-01-31

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 (control group), in breast cancer patients with chronic upper extremity lymphedema.

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 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

Conditions

Lymphedema, Secondary; Lymphedema of Upper Limb

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Negative Pressure

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

Group Type: EXPERIMENTAL

PhysioTouch

Intervention Type: DEVICE

The PhysioTouch is a hand-held device that administers negative pressure under the treatment head, and gently pulls the underlying skin and subcutaneous tissue into the suction cup. This suction produces a stretch to the skin and in the subcutaneous tissue space. This action is thought to facilitate lymphatic flow from the interstitium into the lymphatic vessels, and mobilizes the superficial fascia.

Manual Lymph Drainage

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

Group Type: ACTIVE_COMPARATOR

Manual Lymph Drainage (MLD)

Intervention Type: OTHER

MLD is a practitioner-applied manual massage technique designed to decrease limb volume in patients with lymphedema by enhancing movement of lymph fluid, resulting in reductions in interstitial fluid.

Interventions

PhysioTouch

The PhysioTouch is a hand-held device that administers negative pressure under the treatment head, and gently pulls the underlying skin and subcutaneous tissue into the suction cup. This suction produces a stretch to the skin and in the subcutaneous tissue space. This action is thought to facilitate lymphatic flow from the interstitium into the lymphatic vessels, and mobilizes the superficial fascia.

Intervention Type: DEVICE

Manual Lymph Drainage (MLD)

MLD is a practitioner-applied manual massage technique designed to decrease limb volume in patients with lymphedema by enhancing movement of lymph fluid, resulting in reductions in interstitial fluid.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Foundation for Physical Therapy, Inc.

INDUSTRY

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Betty Smoot, DPTSc, MAS

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California San Francisco

San Francisco, California, United States

Countries

United States

References

Lampinen R, Lee JQ, Leano J, Miaskowski C, Mastick J, Brinker L, Topp K, Smoot B. Treatment of Breast Cancer-Related Lymphedema Using Negative Pressure Massage: A Pilot Randomized Controlled Trial. Arch Phys Med Rehabil. 2021 Aug;102(8):1465-1472.e2. doi: 10.1016/j.apmr.2021.03.022. Epub 2021 Apr 16.

Reference Type: DERIVED

PMID: 33872573 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

View Document

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

NCI-2018-00009

Identifier Type: REGISTRY

Identifier Source: secondary_id

16802

Identifier Type: OTHER

Identifier Source: secondary_id

P0518095

Identifier Type: -

Identifier Source: org_study_id