Clinical trial · Interventional
Breast Edema Compression Vest
The Effect of Wearing a Compression Vest on Patient Reported Pain, Quality of Life and Degree of Breast Edema.
- 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)
A common complication of breast conserving therapy is breast edema, which may lead to chronic pain, but also reduced quality of life (QoL) and poor cosmetic outcome. When pain is present most patients are currently treated with physical therapy, but evidence of its effectiveness is still low and a gold standard does not yet exist. A downside of physical therapy is that patients have to undergo the therapy regularly and treatment might even has to continue for years after symptoms and treatment started. Another treatment option is a compression vest with the potential, apart from reducing symptoms, to improve self-efficacy in patients because they decide when to wear it without the need to visit therapists. However effectiveness of the compression vest has not yet been objectified in studies. The aim of this pilot study is to study if there is an effect on pain, QoL and the amount of breast edema of wearing a compression vest, in order to determine whether a large randomized study is feasible.
Conditions
Conditions (4)
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 Neoplasm | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Edema | — | UNRESOLVED | — |
| Lymphedema | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Compression vest, Thuasne | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- ACTIVE_COMPARATOR
- label
- breast edema vest
- interventionNames
- Device: Compression vest, Thuasne
Primary outcomes (5)
- measure
- Effect of wearing a compression vest on patient reported outcome pain
- timeFrame
- At baseline
- description
- Brief Pain Inventory (BPI) for pain questionnaire
- measure
- Effect of wearing a compression vest on patient reported outcome pain two weeks after wearing a compression vest
- timeFrame
- 2 weeks
- description
- Brief Pain Inventory (BPI) for pain questionnaire
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Females, aged 18 years and older. * Patient treated with surgery and/or radiotherapy for breast cancer, with symptomatic breast edema (e.g. pain). * Visual Analog Scale (VAS) pain score of 3 or more. Exclusion Criteria: * Inability to understand the Dutch language. * Indicated to undergo radiation treatment of the breast/chestwall within the next 6 months. * Cardiac complaints. * Pacemaker. * Port-a-cath. * Thrombosis of the arm. * Pulmonary embolism. * Pulmonary disease. * Pregnancy. * Non-breast cancer related lymph edema. * Clinical depression or anxiety disorder.
References
Publications (0)
Data not yet available