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Treatment of Breast Cancer Related Lymphedema With Cell-assisted Lipotransfer

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ClinicalTrials.gov Identifier: NCT02592213
Recruitment Status : Unknown
Verified September 2016 by Navid Toyserkani, Odense University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : October 30, 2015
Last Update Posted : September 27, 2016
Sponsor:
Information provided by (Responsible Party):
Navid Toyserkani, Odense University Hospital

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.

Condition or disease Intervention/treatment Phase
Lymphedema Procedure: Cell-assisted lipotransfer Phase 2

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Breast Cancer Related Lymphedema With Cell-assisted Lipotransfer
Study Start Date : October 2015
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphedema

Arm Intervention/treatment
Experimental: Treatment
Treatment of lymphedema with cell-assisted lipotransfer using autologous stromal vascular fraction
Procedure: Cell-assisted lipotransfer
Stromal vascular fraction, autologous. Isolated using Celution System (Cytori)




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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

  2. Subjective change assessed LYMQOL questionnaire [ Time Frame: Baseline, 1, 3, 6 and 12 months ]
    Subjective change of lymphedema assessed by questionnaire

  3. Subjective change assessed DASH questionnaire [ Time Frame: Baseline, 1, 3, 6 and 12 months ]
    Subjective change of lymphedema assessed by questionnaire

  4. Change in lymph drainage [ Time Frame: Baseline and 12 months ]
    Change in lymph drainage assessed by lymphoscintigraphy compared with preoperative lymphoscintigraphy

  5. 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

  6. 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



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02592213


Locations
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Denmark
Odense University Hospital
Odense, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
Investigators
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Principal Investigator: Navid M Toyserkani, MD Dept. Plastic and Reconstructive Surgery, Odense University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Navid Toyserkani, MD, Odense University Hospital
ClinicalTrials.gov Identifier: NCT02592213     History of Changes
Other Study ID Numbers: S-20150109
First Posted: October 30, 2015    Key Record Dates
Last Update Posted: September 27, 2016
Last Verified: September 2016
Additional relevant MeSH terms:
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Lymphedema
Breast Cancer Lymphedema
Lymphatic Diseases
Postoperative Complications
Pathologic Processes