Treatment of Breast Cancer Related Lymphedema With Cell-assisted Lipotransfer

Lymphedema Clinical Trial

Official title:

Treatment of Breast Cancer Related Lymphedema With Cell-assisted Lipotransfer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02592213
• Other study ID #: S-20150109
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: October 2015
• Est. completion date: September 2020

Study information

• Verified date: May 2020
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: September 2020
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer Lymphedema
• Lymphedema

Intervention

Procedure:
• Cell-assisted lipotransfer
Stromal vascular fraction, autologous. Isolated using Celution System (Cytori)

Locations

Country	Name	City	State
Denmark	Odense University Hospital	Odense

Sponsors (1)

Lead Sponsor	Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in arm volume	Assessed by clinical measurements	Baseline, 1, 3, 6, 12 and 48 months
Secondary	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
Secondary	Subjective change assessed LYMQOL questionnaire	Subjective change of lymphedema assessed by questionnaire	Baseline, 1, 3, 6, 12 and 48 months
Secondary	Subjective change assessed DASH questionnaire	Subjective change of lymphedema assessed by questionnaire	Baseline, 1, 3, 6, 12 and 48 months
Secondary	Change in lymph drainage	Change in lymph drainage assessed by lymphoscintigraphy compared with preoperative lymphoscintigraphy	Baseline and 12 months
Secondary	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
Secondary	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
Secondary	Change in arm volume	Assessed by DXA scan	Baseline, 3, 6 and 12 months
Secondary	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
Secondary	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