Treatment of Breast Cancer-related Lymphedema With a Negative Pressure Device
Lymphedema, Secondary · Lymphedema of Upper Limb
Bottom Line
View on ClinicalTrials.gov: NCT03252145 ↗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
| Outcome | Result | p-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
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
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.