Overview

This trial is active, not recruiting.

Condition lymphedema
Treatment cell-assisted lipotransfer
Phase phase 2
Sponsor Odense University Hospital
Start date October 2015
End date September 2017
Trial size 10 participants
Trial identifier NCT02592213, S-20150109

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Treatment of lymphedema with cell-assisted lipotransfer using autologous stromal vascular fraction
cell-assisted lipotransfer
Stromal vascular fraction, autologous. Isolated using Celution System (Cytori)

Primary Outcomes

Measure
Change in arm volume
time frame: Baseline, 1 month, 3, 6 months and 12 months

Secondary Outcomes

Measure
Side effects of treatment
time frame: 1, 3, 6 and 12 months
Subjective change assessed LYMQOL questionnaire
time frame: Baseline, 1, 3, 6 and 12 months
Subjective change assessed DASH questionnaire
time frame: Baseline, 1, 3, 6 and 12 months
Change in lymph drainage
time frame: Baseline and 12 months
Subjective change in feeling of tension in arm assessed by numeric scale from 0-10
time frame: Baseline, 1, 3 and 12 months
Subjective change in feeling of heaviness in arm assessed by numeric scale from 0-10
time frame: Baseline, 1, 3, 6 and 12 months

Eligibility Criteria

Female participants from 18 years up to 70 years old.

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.

Additional Information

Official title Treatment of Breast Cancer Related Lymphedema With Cell-assisted Lipotransfer
Principal investigator Navid M Toyserkani, MD
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
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Odense University Hospital.