Breast Cancer LymphedemaPhase 2FGTBRCLNCT02981485
Fat Grafting Used for the Treatment of Breast Cancer Related Lymphedema in China
A Phase 2 study testing Fat Grafting in people with Breast Cancer Lymphedema, run by Peking Union Medical College at 1 site in China.
Trial summary
Breast cancer related lymphedema (BRCL) is a common complication following breast cancer treatment. The incidence of BRCL ranges from 6-50%, depending on the surgical procedure in the axilla and the type of the radiation therapy. Read more about this study
- Who is it for?
- Ages 20 to 60 years, women only
- Conditions the study is for
- Breast Cancer Lymphedema
- What is being tested?
- Fat Grafting
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Dec 2016to Jan 2019
- 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 20 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Breast cancer diagnosis regardless of the date of operation and identified unilateral arm lymphedema Stage Ⅱ of lymphedema according to the standard of International Society of Lymphology The patient is able to read, understand, and complete questionnaires. Completed radiotherapy and/or chemotherapy at least 2 months prior to inclusion The patient understands the nature and purpose of this study and the study procedures and has signed informed consent.
Who cannot join
- Relapse of breast cancer Untreated infection Untreated heart failure Untreated renal failure Untreated deep venous thrombosis in the arm Iodine allergy Pregnancy Psychiatric disorders
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Plastic Surgery Hospital of Chinese Academy of Medical Sciences, Peking Union Medical College
Shijingshan, Beijing Municipality, 100144
Chenglong Wang, MD
Minqiang Xin, MD
About this study
Breast cancer related lymphedema (BRCL) is a common complication following breast cancer treatment. The incidence of BRCL ranges from 6-50%, depending on the surgical procedure in the axilla and the type of the radiation therapy. BRCL can causes cosmetic deformities, impaired physical mobility, mental discomfort, reduced quality of life and erysipelas. Therapy of BRCL is divided into conservative and operative methods. However, all the above method has some shortcomings. It is urgent to investigate new approaches to treat BRCL. In this study, fat grafting is to be used for the treatment of BRCL, and the efficacy and safety of this method will be also assessed.
- Conditions
- Breast Cancer Lymphedema
- Being tested
- Fat Grafting
- Keywords
- Fat Grafting, Breast Cancer Lymphedema
- Medical subject headings
- Breast Cancer Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fat GraftingDevice
Treatment of breast cancer related lymphedema by fat grafting
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Treatment of breast cancer related lymphedema by fat grafting Receives: Device: Fat Grafting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in arm volume
All the patients who received treatment are scanned by 3 dimensional camera, then the volume measurement of the affected and normal arm is managed by software
Measured: Baseline, 3 months, 6months and 12 months
Secondary outcomes (4)
Change in tissue edema
The affected and normal arms of the patients who received treatment are assessed by multi-frequency bioelectrical impedance analysis
Measured: Baseline, 3 months, 6months and 12 months
The function of the lymphatic vessel
The affected arms of the patients who received treatment was assessed by indocyanine green lymphography
Measured: Baseline, 3 months, 6months and 12 months
Side effects of treatment
Any side effects of experimental treatment. The patients who received treatment are asked at each visit
Measured: Baseline, 3 months, 6months and 12 months
Change in quality of life
The patients who received treatment are asked to fill in a questionnaire (EQ-5D- 5 L-questionnaire)
Measured: Baseline 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 posted5 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionJan 2018 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer LymphedemaStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Minqiang Xin, Peking Union Medical College
- Investigators
- Jie Luan, MD, Study director, Plastic Surgery Hospital of Chinese Academy of Medical Sciences, Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02981485
- Sponsor's protocol ID
- CZ2015009
- Acronym
- FGTBRCL
- Status last verified
- Dec 2016
- First submitted
- 1 Dec 2016
- Last updated
- 6 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fat Grafting Used for the Treatment of Breast Cancer Related Lymphedema in China
- ClinicalTrials.gov ID
- NCT02981485
- Acronym / sponsor ID
- FGTBRCL / CZ2015009
- Conditions
- Breast Cancer Lymphedema
- Keywords
- Fat Grafting, Breast Cancer Lymphedema
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Peking Union Medical CollegeUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 5 Dec 2016 (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 related lymphedema (BRCL) is a common complication following breast cancer treatment. The incidence of BRCL ranges from 6-50%, depending on the surgical procedure in the axilla and the type of the radiation therapy. BRCL can causes cosmetic deformities, impaired physical mobility, mental discomfort, reduced quality of life and erysipelas. Therapy of BRCL is divided into conservative and operative methods. However, all the above method has some shortcomings. It is urgent to investigate new approaches to treat BRCL. In this study, fat grafting is to be used for the treatment of BRCL, and the efficacy and safety of this method will be also assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: Fat GraftingTreatment of breast cancer related lymphedema by fat grafting |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Breast cancer diagnosis regardless of the date of operation and identified unilateral arm lymphedema Stage Ⅱ of lymphedema according to the standard of International Society of Lymphology The patient is able to read, understand, and complete questionnaires. Completed radiotherapy and/or chemotherapy at least 2 months prior to inclusion The patient understands the nature and purpose of this study and the study procedures and has signed informed consent.
Key exclusion criteria (1 listed)
- Relapse of breast cancer Untreated infection Untreated heart failure Untreated renal failure Untreated deep venous thrombosis in the arm Iodine allergy Pregnancy Psychiatric disorders
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 |
|---|---|---|
| Fat GraftingTreatment of breast cancer related lymphedema by fat grafting | Device | Experimental |
Primary outcome
Change in arm volume
Time frame: Baseline, 3 months, 6months and 12 months
All the patients who received treatment are scanned by 3 dimensional camera, then the volume measurement of the affected and normal arm is managed by software
4 secondary outcomes
Change in tissue edema
Time frame: Baseline, 3 months, 6months and 12 months
The function of the lymphatic vessel
Time frame: Baseline, 3 months, 6months and 12 months
Side effects of treatment
Time frame: Baseline, 3 months, 6months and 12 months
Change in quality of life
Time frame: Baseline and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2016.
- Individual participant dataSharing planned: No
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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.
Jie Luan, MD study director
Plastic Surgery Hospital of Chinese Academy of Medical Sciences, Peking Union Medical College
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 Fat Grafting in people with Breast Cancer Lymphedema, run by Peking Union Medical College at 1 site in China.
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 1 inclusion and 1 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 6 Dec 2016. 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 China. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Minqiang Xin, MD (+86 10 88772340, doctorshin@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in arm volume (time frame: Baseline, 3 months, 6months and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Dec 2016.