Lymphedema
Conditions
Brief summary
Breast cancer is the most common cancer type among women. Treatment in many cases involves axillary lymphadenectomy followed by radiation therapy. This increases the risk of lymphedema development which occurs in up to 30% of such cases. The present treatment paradigm is conservative with compression garments. There is a need for more effective treatment options and regenerative medicine offers hope for a change to a more curative approach. This Phase 2 trial will examine the efficacy and safety of treatment with freshly isolated adipose-derived stromal cells administered as a cell-assisted lipotransfer to the affected axillary region.
Detailed description
Breast cancer is the most common cancer type among women. Treatment in many cases involves axillary lymphadenectomy followed by radiation therapy. This increases the risk of lymphedema development which occurs in up to 30% of such cases. The present treatment paradigm is conservative with compression garments. There is a need for more effective treatment options and regenerative medicine offers hope for a change to a more curative approach. This Phase 2 trial will examine the efficacy and safety of treatment with freshly isolated adipose-deried stromal cells administered as a cell-assisted lipotransfer to the affected axillary region. Investigators plan to include 10 patients with unilateral lymphedema after previous breast cancer treatment
Interventions
PROCEDURECell-assisted lipotransfer
Stromal vascular fraction, autologous. Isolated using Celution System (Cytori)
Sponsors
Odense University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Unilateral arm lymphedema secondary to breast cancer treatment including lymph node dissection. 2. The patient understands the nature and purpose of this study and the study procedures and has signed informed consent. 3. The opposite upper extremity is healthy. 4. ASA score of 1 or 2. 5. The patient is able to read, understand, and complete Danish questionnaires. 6. Lymphedema grade 1 or 2. A minimum circumference distance of 2cm on either lower or upper arm.
Exclusion criteria
1. The patient is pregnant or lactating. 2. The patient has bilateral lymphedema of the upper extremities. 3. The patient has or has had other malignancies other than breast cancer. 4. The patient is treated with anti-diabetic medication. 5. The patient is diagnosed with any form of psychotic disorder. 6. The patient is smoking.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in arm volume | Baseline, 1, 3, 6, 12 and 48 months | Assessed by clinical measurements |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjective change assessed LYMQOL questionnaire | Baseline, 1, 3, 6, 12 and 48 months | Subjective change of lymphedema assessed by questionnaire |
| Subjective change assessed DASH questionnaire | Baseline, 1, 3, 6, 12 and 48 months | Subjective change of lymphedema assessed by questionnaire |
| Change in lymph drainage | Baseline and 12 months | Change in lymph drainage assessed by lymphoscintigraphy compared with preoperative lymphoscintigraphy |
| Subjective change in feeling of tension in arm assessed by numeric scale from 0-10 | Baseline, 1, 3, 6, 12 and 48 months | Feeling of tension in the arm (separately) 0=healthy and 10=worst imaginable |
| Side effects of treatment | 1, 3, 6, 12 and 48 months | Any side effects of experimental treatment. Assessed by asking the patient at each visit. All reported findings will be reported at study completion |
| Change in arm volume | Baseline, 3, 6 and 12 months | Assessed by DXA scan |
| Number of arm infections | Baseline, 1, 3, 6, 12 and 48 months | Number of arm infections needing antibiotic treatment. Assesed by asking the patient each visit. |
| Change in conservative lymphedema treatment | Baseline, 1, 3, 6, 12 and 48 months | Change in use or type of conservative lymphedema treatments. Assesed by asking the patient each visit. |
| Subjective change in feeling of heaviness in arm assessed by numeric scale from 0-10 | Baseline, 1, 3, 6, 12 and 48 months | Feeling of heaviness in the arm (separately) 0=healthy and 10=worst imaginable |
Countries
Denmark
Outcome results
None listed