Clinical trial NCT03252145: Treatment of Breast Cancer-related Lymphedema With a Negative Pressure Device
Official title: Treatment of Breast Cancer-related Lymphedema With a Negative Pressure Device: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lymphedema, Secondary
Lymphedema of Upper Limb
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Foundation for Physical Therapy, Inc.
First posted: 2017-08-17
Enrollment: 28
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Recruitment Rates
timeFrame: At 4 weeks
measure: Percentage of Participants Who Completed All Study Visits
timeFrame: At 4 weeks
Secondary outcomes:
measure: Mean Limb Volume
timeFrame: At Baseline
measure: Mean Limb Volume
timeFrame: At 4 weeks
measure: Mean Lymphedema Index (L-DEX®) Ratio Scores
timeFrame: At Baseline
measure: Mean L-DEX® Scores
timeFrame: At 4 weeks
measure: Mean Skin Induration Score
timeFrame: At Baseline
measure: Mean Skin Induration Score
timeFrame: At 4 weeks
measure: Mean Degrees of Shoulder Range of Motion
timeFrame: At Baseline
measure: Mean Degrees of Shoulder Range of Motion
timeFrame: At 4 weeks
measure: Mean Grip Score
timeFrame: At Baseline
measure: Mean Grip Score
timeFrame: At 4 weeks
measure: Mean Karnofsky Performance Status (KPS) Score
timeFrame: At Baseline
measure: Mean Karnofsky Performance Status (KPS) Score
timeFrame: At 4 weeks
measure: Mean Self-Administered Comorbidity Questionnaire (SCQ) Scores
timeFrame: At Baseline
measure: Mean Self-Administered Comorbidity Questionnaire (SCQ) Scores
timeFrame: 4 weeks
measure: Mean Norman Questionnaire (NQ) Scores
timeFrame: At Baseline
measure: Mean Norman Questionnaire (NQ) Scores
timeFrame: At 4 weeks
measure: Mean Norman Questionnaire (NQ) Scores
timeFrame: At 4 months
measure: Mean Disability of Arm, Shoulder, Hand Questionnaire (DASH) Scores
timeFrame: At Baseline
measure: Mean Disability of Arm, Shoulder, Hand Questionnaire (DASH) Scores
timeFrame: At 4 weeks
measure: Mean Patient-Reported Outcomes Measurement Information System® (PROMIS) Physical Function for the Upper Extremity (UE)
timeFrame: At Baseline
measure: Mean Patient-Reported Outcomes Measurement Information System® (PROMIS) Physical Function for the Upper Extremity (UE)
timeFrame: At 4 weeks
measure: Mean Scores on the Participant Version of the Patient-Reported Outcomes Measurement Information System (PROMIS®-29) (Version 2)
timeFrame: At Baseline
measure: Mean Scores on the Participant Version of the Patient-Reported Outcomes Measurement Information System (PROMIS®-29) (Version 2)
timeFrame: At 4 weeks
measure: Mean Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores
timeFrame: At Baseline
measure: Mean Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores
timeFrame: At 4 weeks
measure: Mean Body Image Scale (BIS) Score
timeFrame: At baseline
measure: Mean Body Image Scale (BIS) Score
timeFrame: At 4 weeks
measure: Mean Functional Assessment of Chronic Illness Therapy (FACIT) - Treatment Satisfaction - General (TSG) Scores
timeFrame: At 4 weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Betty Smoot, DPTSc, MAS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.