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Treatment of Breast Cancer-related Lymphedema With Stem Cells and Fat Grafting

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ClinicalTrials.gov Identifier: NCT03776721
Recruitment Status : Recruiting
First Posted : December 17, 2018
Last Update Posted : December 24, 2018
Sponsor:
Information provided by (Responsible Party):
Mads Gustaf Jørgensen, Odense University Hospital

Brief Summary:
Breast cancer-related lymphedema is one of the most common and feared consequences of breast cancer treatment. Currently, lymphedema is primarily addressed conservatively with compression garments. Regenerative medicine may provide a new treatment option for lymphedema. This Phase 3 trial will examine the efficacy, effectiveness and safety of freshly isolated adipose-derived stromal cells administered in conjunction with a fat grafting procedure to the affected axillary region.

Condition or disease Intervention/treatment Phase
Lymphedema Procedure: Liposuction Procedure: Fat graft Procedure: Sham graf (Saline injection) Biological: Stem cell injection Procedure: Saline injection Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:

All patients undergo the same liposuction procedure. During general anesthesia, patients are randomized to either fat grafting or sham grafting with saline injection to the axilla. After stem cell suspension, patients receive either stem cell or saline injection depending on randomization using masked syringes.

Participants are blinded, care providers postoperatively are blinded, primary investigator is blinded and all outcome assessors are blinded. The surgeon performing the liposuction and the stem-cell staff are unblinded.

Primary Purpose: Treatment
Official Title: Treatment of Breast Cancer-related Lymphedema With Stem Cells and Fat Grafting
Actual Study Start Date : December 18, 2018
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : September 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphedema

Arm Intervention/treatment
Experimental: Active treatment Procedure: Liposuction
Liposuction is performed on the abdomen or thighs.

Procedure: Fat graft
30mL harvested lipoaspirate is injected at the affected axillary site.
Other Name: lipotransfer

Biological: Stem cell injection
4mL stem cell suspension injected at the affected axillary site.

Placebo Comparator: Placebo treatment Procedure: Liposuction
Liposuction is performed on the abdomen or thighs.

Procedure: Sham graf (Saline injection)
30mL saline is injected at the affected axillary site.

Procedure: Saline injection
4mL saline injected at the affected axillary site.




Primary Outcome Measures :
  1. Change in arm volume [ Time Frame: Baseline, 3, 6, 9 and 12 months ]
    Assessed using clinical circumference measurement


Secondary Outcome Measures :
  1. Safety of treatments: Assessed by asking the patient at each visit [ Time Frame: Baseline, 3, 6, 9 and 12 months ]
    Any side effects to treatments. Assessed by asking the patient at each visit.

  2. Subjective changes assessed using the LYMPH-ICF (Lymphoedema Functioning, Disability and Health) questionaire [ Time Frame: Baseline, 3, 6, 9 and 12 months ]
    Subjective change of lymphedema assessed by questionnaire. Range: 0-100. 100 being the most bothered.

  3. Subjective changes assessed using DASH (DISABILITIES OF THE ARM, SHOULDER AND HAND) questionaire [ Time Frame: Baseline, 3, 6, 9 and 12 months ]
    Subjective change of lymphedema assessed by questionnaire. Range: 1-5. 5 being the most bothered

  4. Subjective changes assessed using SF-36 questionnaire [ Time Frame: Baseline, 3, 6, 9 and 12 months ]
    Subjective change of quality of life assessed by questionnaire. Range: 0-100. 0 being the most bothered.

  5. Change in lymph drainage [ Time Frame: Baseline and 12 months ]
    Change in lymph drainage assessed by indocyanine-green lymphangiography

  6. Change in conservative lymphedema treatment [ Time Frame: Baseline, 3, 6, 9 and 12 months ]
    Change in use or type of conservative lymphedema treatments

  7. Change in adverse lymphedema-related events [ Time Frame: Baseline, 3, 6, 9 and 12 months ]
    Change in infection rates and sick-days due to lymphedema.

  8. Change in L-DEX score (bioimpedance) [ Time Frame: Baseline, 3, 6, 9 and 12 months ]
    Change in L-DEX score of lymphedema arm derived from bioimpedance. Higher values mean more fluid in the lymphedema arm compared to the healthy arm.

  9. Change in weight and arm tissue composition [ Time Frame: Baseline, 3, 6, 9 and 12 months ]
    Assessed using dual energy x-ray absorptiometry (DXA) scan. Change in values from baseline.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Unilateral arm lymphedema secondary to breast cancer treatment including lymph node dissection.
  • Cancer free for at least 1 year
  • 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 (no lymphedema).
  • ASA score of 1 or 2.
  • The patient is able to read, understand, and complete Danish questionnaires.
  • Pitting lymphedema ISL grade 1 or 2.
  • A minimum circumference difference of 2cm or a minimum volume difference of 200mL.

Exclusion Criteria:

  • Pregnant or lactating.
  • Bilateral lymphedema
  • Current or previous malignancies other than breast cancer.
  • Insulin-dependent diabetes.
  • Diagnosed with any form of psychotic disorder, which may impact study participation.
  • Not ceased smoking during treatment.
  • Active implantables (e.g. pacemaker or neurostimulator)
  • Unrealistic treatment expectations.
  • Known hepatitis, HIV or syphilis infection.

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): NCT03776721


Contacts
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Contact: Mads G Jørgensen, MD 22163425 ext +45 Mads.Gustaf.Jorgensen@rsyd.dk

Locations
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Denmark
Department of Plastic and Reconstructive Surgery Recruiting
Odense, Denmark, 5000
Contact: Mads G Jørgensen, MD       Mads.Gustaf.Jorgensen@rsyd.dk   
Contact: Jens A Sørensen, MD, PhD         
Sponsors and Collaborators
Odense University Hospital
Investigators
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Study Chair: Jens A Sørensen, MD, PhD Department of Plastic Surgery, Odense University Hospital

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Responsible Party: Mads Gustaf Jørgensen, Principal Investigator, Odense University Hospital
ClinicalTrials.gov Identifier: NCT03776721     History of Changes
Other Study ID Numbers: S-20180117
First Posted: December 17, 2018    Key Record Dates
Last Update Posted: December 24, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphedema
Breast Cancer Lymphedema
Lymphatic Diseases
Postoperative Complications
Pathologic Processes