Lymphedema
Conditions
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.
Interventions
PROCEDURESham graf (Saline injection)
30mL saline is injected at the affected axillary site.
PROCEDURELiposuction
Liposuction is performed on the abdomen or thighs.
PROCEDUREFat graft
30mL harvested lipoaspirate is injected at the affected axillary site.
BIOLOGICALStem cell injection
4mL stem cell suspension injected at the affected axillary site.
PROCEDURESaline injection
4mL saline injected at the affected axillary site.
Sponsors
Odense University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
All patients undergo the same liposuction procedure. During general anesthesia, patients are randomized to either fat grafting or sham grafting with saline injection to the axilla. After stem cell suspension, patients receive either stem cell or saline injection depending on randomization using masked syringes. Participants are blinded, care providers postoperatively are blinded, primary investigator is blinded and all outcome assessors are blinded. The surgeon performing the liposuction and the stem-cell staff are unblinded.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in arm volume | Baseline, 3, 6, 9 and 12 months | Assessed using clinical circumference measurement |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjective changes assessed using the LYMPH-ICF (Lymphoedema Functioning, Disability and Health) questionaire | Baseline, 3, 6, 9 and 12 months | Subjective change of lymphedema assessed by questionnaire. Range: 0-100. 100 being the most bothered. |
| Subjective changes assessed using DASH (DISABILITIES OF THE ARM, SHOULDER AND HAND) questionaire | Baseline, 3, 6, 9 and 12 months | Subjective change of lymphedema assessed by questionnaire. Range: 1-5. 5 being the most bothered |
| Subjective changes assessed using SF-36 questionnaire | Baseline, 3, 6, 9 and 12 months | Subjective change of quality of life assessed by questionnaire. Range: 0-100. 0 being the most bothered. |
| Change in lymph drainage | Baseline and 12 months | Change in lymph drainage assessed by indocyanine-green lymphangiography |
| Safety of treatments: Assessed by asking the patient at each visit | Baseline, 3, 6, 9 and 12 months | Any side effects to treatments. Assessed by asking the patient at each visit. |
| Change in adverse lymphedema-related events | Baseline, 3, 6, 9 and 12 months | Change in infection rates and sick-days due to lymphedema. |
| Change in L-DEX score (bioimpedance) | Baseline, 3, 6, 9 and 12 months | 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. |
| Change in weight and arm tissue composition | Baseline, 3, 6, 9 and 12 months | Assessed using dual energy x-ray absorptiometry (DXA) scan. Change in values from baseline. |
| Change in conservative lymphedema treatment | Baseline, 3, 6, 9 and 12 months | Change in use or type of conservative lymphedema treatments |
Countries
Denmark
Outcome results
None listed