LymphedemaPhase 1/2NCT02592213
Treatment of Breast Cancer Related Lymphedema With Cell-assisted Lipotransfer
A Phase 1/2 study testing Cell-assisted lipotransfer in people with Lymphedema, run by Odense University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Lymphedema
- What is being tested?
- Cell-assisted lipotransfer
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2015to Sep 2020
- Phase
- Phase 1/2
- 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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unilateral arm lymphedema secondary to breast cancer treatment including lymph node dissection.
- 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.
- ASA score of 1 or 2.
- The patient is able to read, understand, and complete Danish questionnaires.
- Lymphedema grade 1 or 2. A minimum circumference distance of 2cm on either lower or upper arm.
Who cannot join
- The patient is pregnant or lactating.
- The patient has bilateral lymphedema of the upper extremities.
- The patient has or has had other malignancies other than breast cancer.
- The patient is treated with anti-diabetic medication.
- The patient is diagnosed with any form of psychotic disorder.
- The patient is smoking.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Conditions
- Lymphedema
- Being tested
- Cell-assisted lipotransfer
- Medical subject headings
- Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cell-assisted lipotransferProcedure or surgery
Stromal vascular fraction, autologous. Isolated using Celution System (Cytori)
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Treatment of lymphedema with cell-assisted lipotransfer using autologous stromal vascular fraction Receives: Procedure: Cell-assisted lipotransfer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in arm volume
Assessed by clinical measurements
Measured: Baseline, 1, 3, 6, 12 and 48 months
Secondary outcomes (9)
Side effects of treatment
Any side effects of experimental treatment. Assessed by asking the patient at each visit. All reported findings will be reported at study completion
Measured: 1, 3, 6, 12 and 48 months
Subjective change assessed LYMQOL questionnaire
Subjective change of lymphedema assessed by questionnaire
Measured: Baseline, 1, 3, 6, 12 and 48 months
Subjective change assessed DASH questionnaire
Subjective change of lymphedema assessed by questionnaire
Measured: Baseline, 1, 3, 6, 12 and 48 months
Change in lymph drainage
Change in lymph drainage assessed by lymphoscintigraphy compared with preoperative lymphoscintigraphy
Measured: Baseline and 12 months
Subjective change in feeling of tension in arm assessed by numeric scale from 0-10
Feeling of tension in the arm (separately) 0=healthy and 10=worst imaginable
Measured: Baseline, 1, 3, 6, 12 and 48 months
Subjective change in feeling of heaviness in arm assessed by numeric scale from 0-10
Feeling of heaviness in the arm (separately) 0=healthy and 10=worst imaginable
Measured: Baseline, 1, 3, 6, 12 and 48 months
Change in arm volume
Assessed by DXA scan
Measured: Baseline, 3, 6 and 12 months
Number of arm infections
Number of arm infections needing antibiotic treatment. Assesed by asking the patient each visit.
Measured: Baseline, 1, 3, 6, 12 and 48 months
Change in conservative lymphedema treatment
Change in use or type of conservative lymphedema treatments. Assesed by asking the patient each visit.
Measured: Baseline, 1, 3, 6, 12 and 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionSep 2020 (estimated)
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Navid Toyserkani, Odense University Hospital
- Investigators
- Navid M Toyserkani, MD, Principal investigator, Dept. Plastic and Reconstructive Surgery, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02592213
- Sponsor's protocol ID
- S-20150109
- Status last verified
- May 2020
- First submitted
- 28 Oct 2015
- Last updated
- 1 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Toyserkani NM, Jensen CH, Andersen DC, Sheikh SP, Sorensen JA. Treatment of Breast Cancer-Related Lymphedema with Adipose-Derived Regenerative Cells and Fat Grafts: A Feasibility and Safety Study. Stem Cells Transl Med. 2017 Aug;6(8):1666-1672. doi: 10.1002/sctm.17-0037. Epub 2017 Jun 27.
PubMed 28653440Toyserkani NM, Jensen CH, Sheikh SP, Sorensen JA. Cell-Assisted Lipotransfer Using Autologous Adipose-Derived Stromal Cells for Alleviation of Breast Cancer-Related Lymphedema. Stem Cells Transl Med. 2016 Jul;5(7):857-9. doi: 10.5966/sctm.2015-0357. Epub 2016 May 5.
PubMed 27151914
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Breast Cancer Related Lymphedema With Cell-assisted Lipotransfer
- ClinicalTrials.gov ID
- NCT02592213
- Acronym / sponsor ID
- S-20150109
- Conditions
- Lymphedema
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 30 Oct 2015 (estimated)
- 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 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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Procedure: Cell-assisted lipotransferTreatment of lymphedema with cell-assisted lipotransfer using autologous stromal vascular fraction |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Unilateral arm lymphedema secondary to breast cancer treatment including lymph node dissection.
- 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.
- ASA score of 1 or 2.
- The patient is able to read, understand, and complete Danish questionnaires.
Key exclusion criteria (6 listed)
- The patient is pregnant or lactating.
- The patient has bilateral lymphedema of the upper extremities.
- The patient has or has had other malignancies other than breast cancer.
- The patient is treated with anti-diabetic medication.
- The patient is diagnosed with any form of psychotic disorder.
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 |
|---|---|---|
| Cell-assisted lipotransferStromal vascular fraction, autologous. Isolated using Celution System (Cytori) | Procedure or surgery | Treatment |
Primary outcome
Change in arm volume
Time frame: Baseline, 1, 3, 6, 12 and 48 months
Assessed by clinical measurements
9 secondary outcomes
Side effects of treatment
Time frame: 1, 3, 6, 12 and 48 months
Subjective change assessed LYMQOL questionnaire
Time frame: Baseline, 1, 3, 6, 12 and 48 months
Subjective change assessed DASH questionnaire
Time frame: Baseline, 1, 3, 6, 12 and 48 months
Change in lymph drainage
Time frame: Baseline and 12 months
Subjective change in feeling of tension in arm assessed by numeric scale from 0-10
Time frame: Baseline, 1, 3, 6, 12 and 48 months
Subjective change in feeling of heaviness in arm assessed by numeric scale from 0-10
Time frame: Baseline, 1, 3, 6, 12 and 48 months
Change in arm volume
Time frame: Baseline, 3, 6 and 12 months
Number of arm infections
Time frame: Baseline, 1, 3, 6, 12 and 48 months
Change in conservative lymphedema treatment
Time frame: Baseline, 1, 3, 6, 12 and 48 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2020.
- Derived from this study: PubMed 28653440Toyserkani NM, Jensen CH, Andersen DC, Sheikh SP, Sorensen JA. Treatment of Breast Cancer-Related Lymphedema with Adipose-Derived Regenerative Cells and Fat Grafts: A Feasibility and Safety Study. Stem Cells Transl Med. 2017 Aug;6(8):1666-1672. doi: 10.1002/sctm.17-0037. Epub 2017 Jun 27.
- Derived from this study: PubMed 27151914Toyserkani NM, Jensen CH, Sheikh SP, Sorensen JA. Cell-Assisted Lipotransfer Using Autologous Adipose-Derived Stromal Cells for Alleviation of Breast Cancer-Related Lymphedema. Stem Cells Transl Med. 2016 Jul;5(7):857-9. doi: 10.5966/sctm.2015-0357. Epub 2016 May 5.
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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.
Navid M Toyserkani, MD principal investigator
Dept. Plastic and Reconstructive 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 1/2 study testing Cell-assisted lipotransfer 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 6 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 1 Jun 2020. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Results are not available in the source record.
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, 1, 3, 6, 12 and 48 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 NCT02592213, which also lists 2 linked publications.
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 1 Jun 2020.