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Completed

NCT Number: NCT03776721

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

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.

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Key information

Conditions

Lymphedema Hemic and Lymphatic Diseases Lymphatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Plastic and Reconstructive Surgery

Odense, 5000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Liposuction

Procedure

Liposuction is performed on the abdomen or thighs.

Fat graft

Procedure

30mL harvested lipoaspirate is injected at the affected axillary site.

Other names: lipotransfer

Sham graf (Saline injection)

Procedure

30mL saline is injected at the affected axillary site.

stem cell injection

Biological

4mL stem cell suspension injected at the affected axillary site.

Saline injection

Procedure

4mL saline injected at the affected axillary site.

Primary outcomes

  1. Change in arm volume

    Time frame: Baseline, 3, 6, 9 and 12 months

    Assessed using clinical circumference measurement

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Registry information

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Dec 17, 2018
Registry last updated
Jun 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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