Clinical trial · Interventional
Treatment of Breast Cancer-related Lymphedema With a Negative Pressure Device
Treatment of Breast Cancer-related Lymphedema With a Negative Pressure Device: A Feasibility Study
NCT03252145CI-TRIAL-00049465completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphedema of Upper Limb | — | UNRESOLVED | — |
| Lymphedema, Secondary | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Manual Lymph Drainage (MLD) | Other | — | UNRESOLVED |
| PhysioTouch | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Negative Pressure
- description
- PhysioTouch (negative pressure massage) treatment 3 times a week for 4 weeks to the lymphedematous upper limb
- interventionNames
- Device: PhysioTouch
- type
- ACTIVE_COMPARATOR
- label
- Manual Lymph Drainage
- description
- Manual lymph drainage (MLD) treatment 3 times a week for 4 weeks to the lymphedematous upper limb
- interventionNames
- Other: Manual Lymph Drainage (MLD)
Primary outcomes (2)
- measure
- Recruitment Rates
- timeFrame
- At 4 weeks
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDLampinen 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