Clinical trial · Interventional
Preventive Intervention Against Lymphedema After Breast Cancer Surgery
LYCA: Preventive Intervention Against Lymphedema After Breast Cancer Surgery - a Randomized Controlled Trial
NCT02518477CI-TRIAL-00034880LYCAcompletedN/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 study will examine whether lymphedema after breast cancer surgery can be reduced. In a randomised controlled design the aim is to investigate whether an early intervention with progressive resistance training and close monitoring of arm swelling can reduce the incidence of lymphedema after breast cancer surgery.
Conditions
Conditions (1)
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 Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| exercise | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- exercise group
- description
- The first 20 weeks, twice-weekly 60 minute session of physical exercise supervised by the research assistant and once weekly home exercise programme is offered. The exercise intervention will consist of stretching, scar tissue mobilization and resistance exercises. For the following 32 weeks a home-training manual specifying three times weekly training is provided. At week 26 an individual booster session will be offered. In the case of lymphedema, referral to trained lymphedema physiotherapist for evaluation of appropriate intervention is made.
- interventionNames
- Other: exercise
- type
- NO_INTERVENTION
- label
- usual care control group
- description
- Receives all standard care offered from the operating hospital and rehabilitation in the municipality.
Primary outcomes (1)
- measure
- Number of participants with Lymphedema measured by water displacement measurement
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * invasive unilateral breast cancer * undergone Axillary Lymph Node Dissection (ALND), planned for Radiotherapy * Danish speaking * consent to participate and to be randomized to either study arm. Exclusion Criteria: * have undergone primary breast reconstruction * distant metastases * physically unable to participate for any reason * mental illness or cognitive impairment (dementia etc.) * no past history of lymphedema diagnosis or treatment * not previously operated with axillary lymph node dissection either side
References
Publications (0)
Data not yet available
No reference posted for this study.