Clinical trial · Interventional
Effectiveness of Accelerated Intervention With Compression Sleeve in Mild and Moderate Breast Cancer-related Lymphedema
Effectiveness of Accelerated Intervention With Custom-made Compression Sleeve in Women With Mild and Moderate Arm Lymphedema Secondary to Breast Cancer Treatment
NCT01954654CI-TRIAL-00012338unknownN/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)
The purpose of this study is to determine whether accelerated treatment with custom-made compression sleeve is more effective than standard procedure in the treatment of mild and moderate arm lymphedema secondary to primary cancer treatment.
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 |
| Lymphedema | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Custom-made compression sleeve and -gauntlet | Device | — | UNRESOLVED |
| Educational information, recommendation and instruction | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Accelerated treatment
- interventionNames
- Device: Custom-made compression sleeve and -gauntlet
- Other: Educational information, recommendation and instruction
- type
- ACTIVE_COMPARATOR
- label
- Standard treatment
- interventionNames
- Device: Custom-made compression sleeve and -gauntlet
- Other: Educational information, recommendation and instruction
Primary outcomes (1)
- measure
- Change of excess limb volume (ELV)
- timeFrame
- 8 weeks follow-up
- description
- ELV in the affected arm compared to the non-affected arm. ELV described as both absolute volume in ml and relative volume in percent
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 95 Years
Show eligibility criteria text
Inclusion Criteria: * Participants must be refered for the first time due to unilateral arm lymphedema secondary to primary unilateral breast cancer treatment * Participants must be ≥ 2 months after chemo- and radiotherapy * Participants must have ELV ≥10% and \< 30% and/or \> 2 cm difference between the circumference of the two arms at minimum one circumference due to lymphedema * Participants must be motivated for treatment with compression sleeve and -gauntlet * Participants live in and around Aarhus, Denmark Exclusion Criteria: * Known metastatic disease * Contraindication for treatment with compression sleeve * Upper extremity deep venous thrombosis * Previously use of compression sleeve * Known contact allergy to latex * Unable to fill in questionnaire and/or comply with treatment due to lacking Danish language skills, mental state or psychological condition
References
Publications (0)
Data not yet available
No reference posted for this study.