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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
80
Liposuction is performed on the abdomen or thighs.
30mL harvested lipoaspirate is injected at the affected axillary site.
30mL saline is injected at the affected axillary site.
Department of Plastic and Reconstructive Surgery
Odense, Denmark
Change in arm volume
Assessed using clinical circumference measurement
Time frame: Baseline, 3, 6, 9 and 12 months
Safety of treatments: Assessed by asking the patient at each visit
Any side effects to treatments. Assessed by asking the patient at each visit.
Time frame: Baseline, 3, 6, 9 and 12 months
Subjective changes assessed using the LYMPH-ICF (Lymphoedema Functioning, Disability and Health) questionaire
Subjective change of lymphedema assessed by questionnaire. Range: 0-100. 100 being the most bothered.
Time frame: Baseline, 3, 6, 9 and 12 months
Subjective changes assessed using DASH (DISABILITIES OF THE ARM, SHOULDER AND HAND) questionaire
Subjective change of lymphedema assessed by questionnaire. Range: 1-5. 5 being the most bothered
Time frame: Baseline, 3, 6, 9 and 12 months
Subjective changes assessed using SF-36 questionnaire
Subjective change of quality of life assessed by questionnaire. Range: 0-100. 0 being the most bothered.
Time frame: Baseline, 3, 6, 9 and 12 months
Change in lymph drainage
Change in lymph drainage assessed by indocyanine-green lymphangiography
Time frame: Baseline and 12 months
Change in conservative lymphedema treatment
Change in use or type of conservative lymphedema treatments
Time frame: Baseline, 3, 6, 9 and 12 months
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4mL stem cell suspension injected at the affected axillary site.
4mL saline injected at the affected axillary site.
Change in adverse lymphedema-related events
Change in infection rates and sick-days due to lymphedema.
Time frame: Baseline, 3, 6, 9 and 12 months
Change in L-DEX score (bioimpedance)
Change in L-DEX score of lymphedema arm derived from bioimpedance. Higher values mean more fluid in the lymphedema arm compared to the healthy arm.
Time frame: Baseline, 3, 6, 9 and 12 months
Change in weight and arm tissue composition
Assessed using dual energy x-ray absorptiometry (DXA) scan. Change in values from baseline.
Time frame: Baseline, 3, 6, 9 and 12 months