Clinical trial NCT02592213: Treatment of Breast Cancer Related Lymphedema With Cell-assisted Lipotransfer
Official title: Treatment of Breast Cancer Related Lymphedema With Cell-assisted Lipotransfer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Lymphedema
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2015-10-30
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Change in arm volume
timeFrame: Baseline, 1, 3, 6, 12 and 48 months
Secondary outcomes:
measure: Side effects of treatment
timeFrame: 1, 3, 6, 12 and 48 months
measure: Subjective change assessed LYMQOL questionnaire
timeFrame: Baseline, 1, 3, 6, 12 and 48 months
measure: Subjective change assessed DASH questionnaire
timeFrame: Baseline, 1, 3, 6, 12 and 48 months
measure: Change in lymph drainage
timeFrame: Baseline and 12 months
measure: Subjective change in feeling of tension in arm assessed by numeric scale from 0-10
timeFrame: Baseline, 1, 3, 6, 12 and 48 months
measure: Subjective change in feeling of heaviness in arm assessed by numeric scale from 0-10
timeFrame: Baseline, 1, 3, 6, 12 and 48 months
measure: Change in arm volume
timeFrame: Baseline, 3, 6 and 12 months
measure: Number of arm infections
timeFrame: Baseline, 1, 3, 6, 12 and 48 months
measure: Change in conservative lymphedema treatment
timeFrame: Baseline, 1, 3, 6, 12 and 48 months
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
affiliation: Dept. Plastic and Reconstructive Surgery, Odense University Hospital
name: Navid M Toyserkani, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Toyserkani NM, Jensen CH, Andersen DC, Sheikh SP, Sorensen JA. Treatment of Breast Cancer-Related Lymphedema with Adipose-Derived Regenerative Cells and Fat Grafts: A Feasibility and Safety Study. Stem Cells Transl Med. 2017 Aug;6(8):1666-1672. doi: 10.1002/sctm.17-0037. Epub 2017 Jun 27.
citation: Toyserkani NM, Jensen CH, Sheikh SP, Sorensen JA. Cell-Assisted Lipotransfer Using Autologous Adipose-Derived Stromal Cells for Alleviation of Breast Cancer-Related Lymphedema. Stem Cells Transl Med. 2016 Jul;5(7):857-9. doi: 10.5966/sctm.2015-0357. Epub 2016 May 5.