Status:
COMPLETED
Treatment of Breast Cancer-related Lymphedema With Stem Cells and Fat Grafting
Lead Sponsor:
Odense University Hospital
Conditions:
Lymphedema
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Breast cancer-related lymphedema is one of the most common and feared consequences of breast cancer treatment. Currently, lymphedema is primarily addressed conservatively with compression garments. Re...
Eligibility Criteria
Inclusion
- Unilateral arm lymphedema secondary to breast cancer treatment including lymph node dissection.
- Cancer free for at least 1 year
- The patient understands the nature and purpose of this study and the study procedures and has signed informed consent.
- The opposite upper extremity is healthy (no lymphedema).
- ASA score of 1 or 2.
- The patient is able to read, understand, and complete Danish questionnaires.
- Pitting lymphedema ISL grade 1 or 2.
- A minimum circumference difference of 2cm or a minimum volume difference of 200mL.
Exclusion
- Pregnant or lactating.
- Bilateral lymphedema
- Current or previous malignancies other than breast cancer.
- Insulin-dependent diabetes.
- Diagnosed with any form of psychotic disorder, which may impact study participation.
- Not ceased smoking during treatment.
- Active implantables (e.g. pacemaker or neurostimulator)
- Unrealistic treatment expectations.
- Known hepatitis, HIV or syphilis infection.
Key Trial Info
Start Date :
December 18 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2021
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT03776721
Start Date
December 18 2018
End Date
June 1 2021
Last Update
June 25 2021
Active Locations (1)
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1
Department of Plastic and Reconstructive Surgery
Odense, Denmark, 5000