Clinical trial · Interventional
Early Intervention
Preventing the Progression of Low Volume Swelling to Breast Cancer-related Lymphedema: a Pilot Study
NCT05326165CI-TRIAL-00117651not yet recruitingN/AClinicalTrials.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 research study is a Pilot Study examining the use of a compression sleeve with embedded sensor to prevent 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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Breast Cancer Treatment Related Lymphedema | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Compression Sleeve Sensor | Device | — | UNRESOLVED |
| Juzo Compression Sleeve and Glove | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Compression therapy
- description
- Participants will receive a ready to wear compression sleeve and glove with embedded sensor. Compression sleeve will be set to 20-30mm Hg pressure with instructions to wear for 12 hours a day for four consecutive weeks. Participants will also receive a journal to record usage and standard of care post-operative lymphedema monitoring and education and asked to fill out questionnaires.
- interventionNames
- Device: Juzo Compression Sleeve and Glove
- Device: Compression Sleeve Sensor
Primary outcomes (1)
- measure
- Arm Volume
- timeFrame
- 1, 3, 6, 9 and 12 months
- description
- Primary objective is efficacy of compression intervention to change rate of progression from low volume swelling (LVS) (relative volume change (RVC) 5-\<10%) to breast cancer-related lymphedema (BCRL) (RVC \>/=10%). Measurement of effect of the compression intervention will be completed with arm volume measurements using perometry (infrared optical electronic scanner) .
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Eligible participants will be female, \>/= 18 years, who underwent BC surgery for invasive or in-situ carcinoma with unilateral axillary lymph node dissection (ALND) (with or without contralateral prophylactic SLNB). Because of the extremely low incidence of BC in children and males, only female participants over the age of 18 will be included. * Eligible participants will demonstrate low volume swelling (RVC 5-\<10%) \>/=12 weeks postoperatively * Eligible participants will read and comprehend English, with the ability to understand and the willingness to sign a written consent document. * Most patients treated for breast cancer will have undergone SLNB for axillary staging, and are therefore at lower risk for BCRL, compared to patients with ALND and/or regional lymph node radiation (RLNR). We have chosen to include only patients at high risk of BCRL, i.e., those who have undergone ALND, and we will not be including those who are at low BCRL risk, i.e., had only SLNB for axillary staging on the side of BC. Exclusion Criteria: * Participants who have bilateral BC (ie. contralateral staging SLNB or ALND) will not be eligible due to the need of a contralateral control arm for the RVC equation. * Participants will not be eligible if they have been diagnosed and/or treated for BCRL. * Participants will not be eligible if they have metastases that may cause BCRL. Participants with metastatic disease will be excluded. * Participants with implanted cardiac devices and those who are pregnant will be excluded from the Sozo measurement component of the study.
References
Publications (0)
Data not yet available
No reference posted for this study.