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N/A N=28 Randomized Single-blind Treatment

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

Lymphedema, Secondary · Lymphedema of Upper Limb

Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcome: Primary: Recruitment Rates — 32.5; 37.5 rate of recruitment

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
PhysioTouch (Device); Manual Lymph Drainage (MLD) (Other)
Age
Adult, Older Adult · 18+ yrs
Sex
Female
Sponsor
University of California, San Francisco
Primary completion
Jan 2020

Outcome Measures

OutcomeResultp-value
PRIMARY
Recruitment Rates
32.5; 37.5
PRIMARY
Percentage of Participants Who Completed All Study Visits
84.6; 86.7
SECONDARY
Mean Limb Volume
352.66; 512.98 0.206
SECONDARY
Mean Limb Volume
352.66; 512.98 0.206
SECONDARY
Mean Lymphedema Index (L-DEX®) Ratio Scores
23.09; 34.16 0.096
SECONDARY
Mean L-DEX® Scores
26.30; 30.09 0.206
SECONDARY
Mean Skin Induration Score
0.069; 0.065 0.498
SECONDARY
Mean Skin Induration Score
0.069; 0.065 0.498
SECONDARY
Mean Degrees of Shoulder Range of Motion
170.5; 165.5; 169.3; 164.6 0.125
SECONDARY
Mean Degrees of Shoulder Range of Motion
170.5; 165.5; 169.3; 164.6 0.125
SECONDARY
Mean Grip Score
26.4; 25.2; 25.5; 22.6 0.596
SECONDARY
Mean Grip Score
26.4; 25.2; 25.5; 22.6 0.596
SECONDARY
Mean Karnofsky Performance Status (KPS) Score
91.8; 90.91 0.772
SECONDARY
Mean Karnofsky Performance Status (KPS) Score
91.8; 90.91 0.772
SECONDARY
Mean Self-Administered Comorbidity Questionnaire (SCQ) Scores
2.25; 3.42 0.300
SECONDARY
Mean Self-Administered Comorbidity Questionnaire (SCQ) Scores
2.25; 3.42 0.300
SECONDARY
Mean Norman Questionnaire (NQ) Scores
2.71; 4.56 0.138
SECONDARY
Mean Norman Questionnaire (NQ) Scores
2.71; 4.56 0.138
SECONDARY
Mean Norman Questionnaire (NQ) Scores
2.71; 4.56 0.138
SECONDARY
Mean Disability of Arm, Shoulder, Hand Questionnaire (DASH) Scores
11.20; 17.62 0.206
SECONDARY
Mean Disability of Arm, Shoulder, Hand Questionnaire (DASH) Scores
11.20; 17.62 0.206
SECONDARY
Mean Patient-Reported Outcomes Measurement Information System® (PROMIS) Physical Function for the Upper Extremity (UE)
49.35; 43.14 0.080
SECONDARY
Mean Patient-Reported Outcomes Measurement Information System® (PROMIS) Physical Function for the Upper Extremity (UE)
49.35; 43.14 0.080
SECONDARY
Mean Scores on the Participant Version of the Patient-Reported Outcomes Measurement Information System (PROMIS®-29) (Version 2)
19.8; 17.2; 4.9; 6.7; 4.5; 5.1 0.038 sig
SECONDARY
Mean Scores on the Participant Version of the Patient-Reported Outcomes Measurement Information System (PROMIS®-29) (Version 2)
19.8; 17.2; 4.9; 6.7; 4.5; 5.1 0.038 sig
SECONDARY
Mean Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores
118.4; 114.7 0.603
SECONDARY
Mean Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores
118.4; 114.7 0.603
SECONDARY
Mean Body Image Scale (BIS) Score
7.7; 9.5 0.511
SECONDARY
Mean Body Image Scale (BIS) Score
7.7; 9.5 0.511
SECONDARY
Mean Functional Assessment of Chronic Illness Therapy (FACIT) - Treatment Satisfaction - General (TSG) Scores
24.6; 27.0 0.326

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.

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03252145). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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