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

Primary Purpose

Lymphedema

Status
Completed
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Liposuction
Fat graft
Sham graf (Saline injection)
Stem cell injection
Saline injection
Sponsored by
Odense University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphedema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Plastic and Reconstructive Surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active treatment

Placebo treatment

Arm Description

Outcomes

Primary Outcome Measures

Change in arm volume
Assessed using clinical circumference measurement

Secondary Outcome Measures

Safety of treatments: Assessed by asking the patient at each visit
Any side effects to treatments. Assessed by asking the patient at each visit.
Subjective changes assessed using the LYMPH-ICF (Lymphoedema Functioning, Disability and Health) questionaire
Subjective change of lymphedema assessed by questionnaire. Range: 0-100. 100 being the most bothered.
Subjective changes assessed using DASH (DISABILITIES OF THE ARM, SHOULDER AND HAND) questionaire
Subjective change of lymphedema assessed by questionnaire. Range: 1-5. 5 being the most bothered
Subjective changes assessed using SF-36 questionnaire
Subjective change of quality of life assessed by questionnaire. Range: 0-100. 0 being the most bothered.
Change in lymph drainage
Change in lymph drainage assessed by indocyanine-green lymphangiography
Change in conservative lymphedema treatment
Change in use or type of conservative lymphedema treatments
Change in adverse lymphedema-related events
Change in infection rates and sick-days due to lymphedema.
Change in L-DEX score (bioimpedance)
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.
Change in weight and arm tissue composition
Assessed using dual energy x-ray absorptiometry (DXA) scan. Change in values from baseline.

Full Information

First Posted
November 12, 2018
Last Updated
June 24, 2021
Sponsor
Odense University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03776721
Brief Title
Treatment of Breast Cancer-related Lymphedema With Stem Cells and Fat Grafting
Official Title
Treatment of Breast Cancer-related Lymphedema With Stem Cells and Fat Grafting
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
December 18, 2018 (Actual)
Primary Completion Date
June 1, 2021 (Actual)
Study Completion Date
June 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Odense University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

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 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active treatment
Arm Type
Experimental
Arm Title
Placebo treatment
Arm Type
Placebo Comparator
Intervention Type
Procedure
Intervention Name(s)
Liposuction
Intervention Description
Liposuction is performed on the abdomen or thighs.
Intervention Type
Procedure
Intervention Name(s)
Fat graft
Other Intervention Name(s)
lipotransfer
Intervention Description
30mL harvested lipoaspirate is injected at the affected axillary site.
Intervention Type
Procedure
Intervention Name(s)
Sham graf (Saline injection)
Intervention Description
30mL saline is injected at the affected axillary site.
Intervention Type
Biological
Intervention Name(s)
Stem cell injection
Intervention Description
4mL stem cell suspension injected at the affected axillary site.
Intervention Type
Procedure
Intervention Name(s)
Saline injection
Intervention Description
4mL saline injected at the affected axillary site.
Primary Outcome Measure Information:
Title
Change in arm volume
Description
Assessed using clinical circumference measurement
Time Frame
Baseline, 3, 6, 9 and 12 months
Secondary Outcome Measure Information:
Title
Safety of treatments: Assessed by asking the patient at each visit
Description
Any side effects to treatments. Assessed by asking the patient at each visit.
Time Frame
Baseline, 3, 6, 9 and 12 months
Title
Subjective changes assessed using the LYMPH-ICF (Lymphoedema Functioning, Disability and Health) questionaire
Description
Subjective change of lymphedema assessed by questionnaire. Range: 0-100. 100 being the most bothered.
Time Frame
Baseline, 3, 6, 9 and 12 months
Title
Subjective changes assessed using DASH (DISABILITIES OF THE ARM, SHOULDER AND HAND) questionaire
Description
Subjective change of lymphedema assessed by questionnaire. Range: 1-5. 5 being the most bothered
Time Frame
Baseline, 3, 6, 9 and 12 months
Title
Subjective changes assessed using SF-36 questionnaire
Description
Subjective change of quality of life assessed by questionnaire. Range: 0-100. 0 being the most bothered.
Time Frame
Baseline, 3, 6, 9 and 12 months
Title
Change in lymph drainage
Description
Change in lymph drainage assessed by indocyanine-green lymphangiography
Time Frame
Baseline and 12 months
Title
Change in conservative lymphedema treatment
Description
Change in use or type of conservative lymphedema treatments
Time Frame
Baseline, 3, 6, 9 and 12 months
Title
Change in adverse lymphedema-related events
Description
Change in infection rates and sick-days due to lymphedema.
Time Frame
Baseline, 3, 6, 9 and 12 months
Title
Change in L-DEX score (bioimpedance)
Description
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.
Time Frame
Baseline, 3, 6, 9 and 12 months
Title
Change in weight and arm tissue composition
Description
Assessed using dual energy x-ray absorptiometry (DXA) scan. Change in values from baseline.
Time Frame
Baseline, 3, 6, 9 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens A Sørensen, MD, PhD
Organizational Affiliation
Department of Plastic Surgery, Odense University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Plastic and Reconstructive Surgery
City
Odense
ZIP/Postal Code
5000
Country
Denmark

12. IPD Sharing Statement

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

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