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

NCT03252145 | Completed Results DMC FDA Device

• 3 other identifiers: P0518095NCI-2018-0000916802
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphedema, Secondary; Lymphedema of Upper Limb

Outcome Measures

Primary Outcomes (2)

• Recruitment Rates

  The recruitment rate is defined as the number of women who were screened and then enrolled on the study divided by the the total number of women screened overall.

  At 4 weeks

• Percentage of Participants Who Completed All Study Visits

  Retention rates for both arms of this study were evaluated. The numbers of women who completed the study will be recorded. Reasons for drop out will be ascertained.

  At 4 weeks

Secondary Outcomes (28)

• Mean Limb Volume

  At Baseline

• Mean Limb Volume

  At 4 weeks

• Mean Lymphedema Index (L-DEX®) Ratio Scores

  At Baseline

• Mean L-DEX® Scores

  At 4 weeks

• Mean Skin Induration Score

  At Baseline

Study Arms (2)

Negative Pressure

EXPERIMENTAL

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

Device: PhysioTouch

Manual Lymph Drainage

ACTIVE COMPARATOR

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

Other: Manual Lymph Drainage (MLD)

Interventions

PhysioTouch 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.

Negative Pressure

Manual Lymph Drainage (MLD) 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.

Manual Lymph Drainage

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• Foundation for Physical Therapy, Inc.: collaborator

Study Sites (1)

University of California San Francisco

San Francisco, California, 94158, United States

Location

Related Publications (1)

• 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.

  PMID: 33872573 DERIVED

MeSH Terms

Conditions

Lymphedema; Neoplasm Metastasis

Interventions

Manual Lymphatic Drainage

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Massage; Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Drainage; Physical Therapy Modalities; Rehabilitation

Results Point of Contact

• Title: Betty Smoot, DPTSc, PT
• Organization: University of California, San Francisco

Betty.Smoot@ucsf.edu

(707) 494-8262

Study Officials

• Betty Smoot, DPTSc, MAS

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2017
• First Posted: August 17, 2017
• Study Start: October 31, 2017
• Primary Completion: January 31, 2020
• Study Completion: January 31, 2020
• Last Updated: January 15, 2021
• Results First Posted: January 8, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)