Treatment of Breast Cancer Related Lymphedema With Cell-assisted Lipotransfer

Study Overview
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Brief Summary
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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
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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

Official Title
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Treatment of Breast Cancer Related Lymphedema With Cell-assisted Lipotransfer

Conditions
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Lymphedema

Intervention / Treatment
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* Procedure: Cell-assisted lipotransfer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Unilateral arm lymphedema secondary to breast cancer treatment including lymph node dissection. 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. ASA score of 1 or 2. The patient is able to read, understand, and complete Danish questionnaires. Lymphedema grade 1 or 2. A minimum circumference distance of 2cm on either lower or upper arm. Exclusion Criteria: The patient is pregnant or lactating. The patient has bilateral lymphedema of the upper extremities. The patient has or has had other malignancies other than breast cancer. The patient is treated with anti-diabetic medication. The patient is diagnosed with any form of psychotic disorder. The patient is smoking.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Treatment of lymphedema with cell-assisted lipotransfer using autologous stromal vascular fraction | Procedure: Cell-assisted lipotransfer<br>* Stromal vascular fraction, autologous. Isolated using Celution System (Cytori)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in arm volume | Assessed by clinical measurements | Baseline, 1, 3, 6, 12 and 48 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effects of treatment | Any side effects of experimental treatment. Assessed by asking the patient at each visit. All reported findings will be reported at study completion | 1, 3, 6, 12 and 48 months | 
| Subjective change assessed LYMQOL questionnaire | Subjective change of lymphedema assessed by questionnaire | Baseline, 1, 3, 6, 12 and 48 months | 
| Subjective change assessed DASH questionnaire | Subjective change of lymphedema assessed by questionnaire | Baseline, 1, 3, 6, 12 and 48 months | 
| Change in lymph drainage | Change in lymph drainage assessed by lymphoscintigraphy compared with preoperative lymphoscintigraphy | Baseline and 12 months | 
| Subjective change in feeling of tension in arm assessed by numeric scale from 0-10 | Feeling of tension in the arm (separately) 0=healthy and 10=worst imaginable | Baseline, 1, 3, 6, 12 and 48 months | 
| Subjective change in feeling of heaviness in arm assessed by numeric scale from 0-10 | Feeling of heaviness in the arm (separately) 0=healthy and 10=worst imaginable | Baseline, 1, 3, 6, 12 and 48 months | 
| Change in arm volume | Assessed by DXA scan | Baseline, 3, 6 and 12 months | 
| Number of arm infections | Number of arm infections needing antibiotic treatment. Assesed by asking the patient each visit. | Baseline, 1, 3, 6, 12 and 48 months | 
| Change in conservative lymphedema treatment | Change in use or type of conservative lymphedema treatments. Assesed by asking the patient each visit. | Baseline, 1, 3, 6, 12 and 48 months |