Treatment of Breast Cancer Related Lymphedema With Cell-assisted Lipotransfer

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 2017

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

Interventions

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

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • Change in arm volume
    • Time Frame: Baseline, 1 month, 3, 6 months and 12 months
    • Assessed by clinical measurements (1,3, 6 and 12 months) Assessed by DXA scan (3 and 12 months).

Secondary Measures

  • Side effects of treatment
    • Time Frame: 1, 3, 6 and 12 months
    • 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
    • Time Frame: Baseline, 1, 3, 6 and 12 months
    • Subjective change of lymphedema assessed by questionnaire
  • Subjective change assessed DASH questionnaire
    • Time Frame: Baseline, 1, 3, 6 and 12 months
    • Subjective change of lymphedema assessed by questionnaire
  • Change in lymph drainage
    • Time Frame: Baseline and 12 months
    • 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
    • Time Frame: Baseline, 1, 3 and 12 months
    • 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
    • Time Frame: Baseline, 1, 3, 6 and 12 months
    • Feeling of heaviness in the arm (separately) 0=healthy and 10=worst imaginable

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Odense University Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Navid Toyserkani, MD – Odense University Hospital
  • Overall Official(s)
    • Navid M Toyserkani, MD, Principal Investigator, Dept. Plastic and Reconstructive Surgery, Odense University Hospital

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