LymphedemaPhase 2NCT03776721
Treatment of Breast Cancer-related Lymphedema With Stem Cells and Fat Grafting
A Phase 2 study testing Liposuction, Fat graft and Stem cell injection in people with Lymphedema, run by Odense University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphedema
- What is being tested?
- Liposuction, Fat graft and Stem cell injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteDenmark
- Study dates
- 18 Dec 2018to 1 Jun 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- Active implantables (e.g. pacemaker or neurostimulator)
- Unrealistic treatment expectations.
- Known hepatitis, HIV or syphilis infection.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Lymphedema
- Being tested
- Liposuction, Fat graft, Sham graf (Saline injection), Stem cell injection, Saline injection
- Medical subject headings
- Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LiposuctionProcedure or surgery
Liposuction is performed on the abdomen or thighs.
Fat graftProcedure or surgery
Also called lipotransfer
30mL harvested lipoaspirate is injected at the affected axillary site.
Sham graf (Saline injection)Procedure or surgery
30mL saline is injected at the affected axillary site.
Stem cell injectionBiological
4mL stem cell suspension injected at the affected axillary site.
Saline injectionProcedure or surgery
4mL saline injected at the affected axillary site.
| Study group | Role | What they receive |
|---|---|---|
| Active treatment | Experimental | Not described Receives: Procedure: Liposuction; Procedure: Fat graft; Biological: Stem cell injection |
| Placebo treatment | Placebo comparator | Not described Receives: Procedure: Liposuction; Procedure: Sham graf (Saline injection); Procedure: Saline injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in arm volume
Assessed using clinical circumference measurement
Measured: Baseline, 3, 6, 9 and 12 months
Secondary outcomes (9)
Safety of treatments: Assessed by asking the patient at each visit
Any side effects to treatments. Assessed by asking the patient at each visit.
Measured: Baseline, 3, 6, 9 and 12 months
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.
Measured: Baseline, 3, 6, 9 and 12 months
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
Measured: Baseline, 3, 6, 9 and 12 months
Subjective changes assessed using SF-36 questionnaire
Subjective change of quality of life assessed by questionnaire. Range: 0-100. 0 being the most bothered.
Measured: Baseline, 3, 6, 9 and 12 months
Change in lymph drainage
Change in lymph drainage assessed by indocyanine-green lymphangiography
Measured: Baseline and 12 months
Change in conservative lymphedema treatment
Change in use or type of conservative lymphedema treatments
Measured: Baseline, 3, 6, 9 and 12 months
Change in adverse lymphedema-related events
Change in infection rates and sick-days due to lymphedema.
Measured: Baseline, 3, 6, 9 and 12 months
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.
Measured: Baseline, 3, 6, 9 and 12 months
Change in weight and arm tissue composition
Assessed using dual energy x-ray absorptiometry (DXA) scan. Change in values from baseline.
Measured: Baseline, 3, 6, 9 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2018
- Study start18 Dec 2018
- Primary completion1 Jun 2021
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LymphedemaStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mads Gustaf Jørgensen, Odense University Hospital
- Investigators
- Jens A Sørensen, MD, PhD, Study chair, Department of Plastic Surgery, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03776721
- Sponsor's protocol ID
- S-20180117
- Status last verified
- Jun 2021
- First submitted
- 12 Nov 2018
- Last updated
- 25 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jorgensen MG, Jensen CH, Hermann AP, Andersen DC, Toyserkani NM, Sheikh SP, Sorensen JA. No Clinical Efficacy of Adipose-Derived Regenerative Cells and Lipotransfer in Breast Cancer-Related Lymphedema: A Double-Blind Placebo-Controlled Phase II Trial. Plast Reconstr Surg. 2024 Dec 1;154(6):1172-1182. doi: 10.1097/PRS.0000000000011343. Epub 2024 Feb 7.
PubMed 39591365
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Breast Cancer-related Lymphedema With Stem Cells and Fat Grafting
- ClinicalTrials.gov ID
- NCT03776721
- Acronym / sponsor ID
- S-20180117
- Conditions
- Lymphedema
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- 18 Dec 2018 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 17 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active treatment | Experimental | Procedure: Liposuction, Procedure: Fat graft, Biological: Stem cell injection |
| Placebo treatment | Placebo comparator | Procedure: Liposuction, Procedure: Sham graf (Saline injection), Procedure: Saline injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LiposuctionLiposuction is performed on the abdomen or thighs. | Procedure or surgery | Active treatment, Placebo treatment |
| Fat graftAlso: lipotransfer30mL harvested lipoaspirate is injected at the affected axillary site. | Procedure or surgery | Active treatment |
| Sham graf (Saline injection)30mL saline is injected at the affected axillary site. | Procedure or surgery | Placebo treatment |
| Stem cell injection4mL stem cell suspension injected at the affected axillary site. | Biological | Active treatment |
| Saline injection4mL saline injected at the affected axillary site. | Procedure or surgery | Placebo treatment |
Primary outcome
Change in arm volume
Time frame: Baseline, 3, 6, 9 and 12 months
Assessed using clinical circumference measurement
9 secondary outcomes
Safety of treatments: Assessed by asking the patient at each visit
Time frame: Baseline, 3, 6, 9 and 12 months
Subjective changes assessed using the LYMPH-ICF (Lymphoedema Functioning, Disability and Health) questionaire
Time frame: Baseline, 3, 6, 9 and 12 months
Subjective changes assessed using DASH (DISABILITIES OF THE ARM, SHOULDER AND HAND) questionaire
Time frame: Baseline, 3, 6, 9 and 12 months
Subjective changes assessed using SF-36 questionnaire
Time frame: Baseline, 3, 6, 9 and 12 months
Change in lymph drainage
Time frame: Baseline and 12 months
Change in conservative lymphedema treatment
Time frame: Baseline, 3, 6, 9 and 12 months
Change in adverse lymphedema-related events
Time frame: Baseline, 3, 6, 9 and 12 months
Change in L-DEX score (bioimpedance)
Time frame: Baseline, 3, 6, 9 and 12 months
Change in weight and arm tissue composition
Time frame: Baseline, 3, 6, 9 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2021.
- Derived from this study: PubMed 39591365Jorgensen MG, Jensen CH, Hermann AP, Andersen DC, Toyserkani NM, Sheikh SP, Sorensen JA. No Clinical Efficacy of Adipose-Derived Regenerative Cells and Lipotransfer in Breast Cancer-Related Lymphedema: A Double-Blind Placebo-Controlled Phase II Trial. Plast Reconstr Surg. 2024 Dec 1;154(6):1172-1182. doi: 10.1097/PRS.0000000000011343. Epub 2024 Feb 7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens A Sørensen, MD, PhD study chair
Department of Plastic Surgery, Odense University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Liposuction, Fat graft and Stem cell injection in people with Lymphedema, run by Odense University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in arm volume (time frame: Baseline, 3, 6, 9 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03776721, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2021.