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Treatment of Breast Cancer Related Lymphedema With Cell-assisted Lipotransfer

Primary Purpose

Lymphedema

Status

Unknown status

Phase

Phase 1

Locations

Denmark

Study Type

Interventional

Intervention

Cell-assisted lipotransfer

About this trial

This is an interventional treatment trial for Lymphedema

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Odense University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

Treatment of lymphedema with cell-assisted lipotransfer using autologous stromal vascular fraction

Outcomes

Primary Outcome Measures

Change in arm volume

Assessed by clinical measurements

Secondary Outcome Measures

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

Subjective change assessed LYMQOL questionnaire

Subjective change of lymphedema assessed by questionnaire

Subjective change assessed DASH questionnaire

Subjective change of lymphedema assessed by questionnaire

Change in lymph drainage

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

Feeling of tension in the arm (separately) 0=healthy and 10=worst imaginable

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

Change in arm volume

Assessed by DXA scan

Number of arm infections

Number of arm infections needing antibiotic treatment. Assesed by asking the patient each visit.

Change in conservative lymphedema treatment

Change in use or type of conservative lymphedema treatments. Assesed by asking the patient each visit.

Full Information

NCT ID

NCT02592213

First Posted

October 28, 2015

Last Updated

May 28, 2020

Sponsor

Odense University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02592213

Brief Title

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

2. Study Status

Record Verification Date

May 2020

Overall Recruitment Status

Unknown status

Study Start Date

October 2015 (undefined)

Primary Completion Date

September 2020 (Anticipated)

Study Completion Date

September 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Odense University Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lymphedema

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treatment

Arm Type

Experimental

Arm Description

Treatment of lymphedema with cell-assisted lipotransfer using autologous stromal vascular fraction

Intervention Type

Procedure

Intervention Name(s)

Cell-assisted lipotransfer

Intervention Description

Stromal vascular fraction, autologous. Isolated using Celution System (Cytori)

Primary Outcome Measure Information:

Title

Change in arm volume

Description

Assessed by clinical measurements

Time Frame

Baseline, 1, 3, 6, 12 and 48 months

Secondary Outcome Measure Information:

Title

Side effects of treatment

Description

Any side effects of experimental treatment. Assessed by asking the patient at each visit. All reported findings will be reported at study completion

Time Frame

1, 3, 6, 12 and 48 months

Title

Subjective change assessed LYMQOL questionnaire

Description

Subjective change of lymphedema assessed by questionnaire

Time Frame

Baseline, 1, 3, 6, 12 and 48 months

Title

Subjective change assessed DASH questionnaire

Description

Subjective change of lymphedema assessed by questionnaire

Time Frame

Baseline, 1, 3, 6, 12 and 48 months

Title

Change in lymph drainage

Description

Change in lymph drainage assessed by lymphoscintigraphy compared with preoperative lymphoscintigraphy

Time Frame

Baseline and 12 months

Title

Subjective change in feeling of tension in arm assessed by numeric scale from 0-10

Description

Feeling of tension in the arm (separately) 0=healthy and 10=worst imaginable

Time Frame

Baseline, 1, 3, 6, 12 and 48 months

Title

Subjective change in feeling of heaviness in arm assessed by numeric scale from 0-10

Description

Feeling of heaviness in the arm (separately) 0=healthy and 10=worst imaginable

Time Frame

Baseline, 1, 3, 6, 12 and 48 months

Title

Change in arm volume

Description

Assessed by DXA scan

Time Frame

Baseline, 3, 6 and 12 months

Title

Number of arm infections

Description

Number of arm infections needing antibiotic treatment. Assesed by asking the patient each visit.

Time Frame

Baseline, 1, 3, 6, 12 and 48 months

Title

Change in conservative lymphedema treatment

Description

Change in use or type of conservative lymphedema treatments. Assesed by asking the patient each visit.

Time Frame

Baseline, 1, 3, 6, 12 and 48 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Navid M Toyserkani, MD

Organizational Affiliation

Dept. Plastic and Reconstructive Surgery, Odense University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Odense University Hospital

City

Odense

ZIP/Postal Code

5000

Country

Denmark

12. IPD Sharing Statement

Citations:

PubMed Identifier

28653440

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.

Results Reference

derived

PubMed Identifier

27151914

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.

Results Reference

derived

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Treatment of Breast Cancer Related Lymphedema With Cell-assisted Lipotransfer

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