Clinical trial NCT03776721: Treatment of Breast Cancer-related Lymphedema With Stem Cells and Fat Grafting
Official title: Treatment of Breast Cancer-related Lymphedema With Stem Cells and Fat Grafting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lymphedema
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2018-12-17
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. Regenerative medicine may provide a new treatment option for lymphedema. This Phase 3 trial will examine the efficacy, effectiveness and safety of freshly isolated adipose-derived stromal cells administered in conjunction with a fat grafting procedure to the affected axillary region.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Change in arm volume
timeFrame: Baseline, 3, 6, 9 and 12 months
Secondary outcomes:
measure: Safety of treatments: Assessed by asking the patient at each visit
timeFrame: Baseline, 3, 6, 9 and 12 months
measure: Subjective changes assessed using the LYMPH-ICF (Lymphoedema Functioning, Disability and Health) questionaire
timeFrame: Baseline, 3, 6, 9 and 12 months
measure: Subjective changes assessed using DASH (DISABILITIES OF THE ARM, SHOULDER AND HAND) questionaire
timeFrame: Baseline, 3, 6, 9 and 12 months
measure: Subjective changes assessed using SF-36 questionnaire
timeFrame: Baseline, 3, 6, 9 and 12 months
measure: Change in lymph drainage
timeFrame: Baseline and 12 months
measure: Change in conservative lymphedema treatment
timeFrame: Baseline, 3, 6, 9 and 12 months
measure: Change in adverse lymphedema-related events
timeFrame: Baseline, 3, 6, 9 and 12 months
measure: Change in L-DEX score (bioimpedance)
timeFrame: Baseline, 3, 6, 9 and 12 months
measure: Change in weight and arm tissue composition
timeFrame: Baseline, 3, 6, 9 and 12 months
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Department of Plastic and Reconstructive Surgery
Study officials:
affiliation: Department of Plastic Surgery, Odense University Hospital
name: Jens A Sørensen, MD, PhD
role: STUDY_CHAIR
References: