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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Treatment of breast cancer related lymphedema by fat grafting |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fat Grafting | Device | Treatment of breast cancer related lymphedema by fat grafting |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline, 3 months, 6months and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in tissue edema | The affected and normal arms of the patients who received treatment are assessed by multi-frequency bioelectrical impedance analysis | Baseline, 3 months, 6months and 12 months |
| The function of the lymphatic vessel |
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Inclusion Criteria:
Breast cancer diagnosis regardless of the date of operation and identified unilateral arm lymphedema Stage â…¡ 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.
Exclusion Criteria:
Relapse of breast cancer Untreated infection Untreated heart failure Untreated renal failure Untreated deep venous thrombosis in the arm Iodine allergy Pregnancy Psychiatric disorders
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Minqiang Xin, MD | Contact | +86 10 88772340 | doctorshin@163.com | |
| Chenglong Wang, MD | Contact | +86 10 88772076 | likexfz@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Jie Luan, MD | Plastic Surgery Hospital of Chinese Academy of Medical Sciences, Peking Union Medical College | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Plastic Surgery Hospital of Chinese Academy of Medical Sciences, Peking Union Medical College | Recruiting | Shijingshan | Beijing Municipality | 100144 | China |
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| ID | Term |
|---|---|
| D000072656 | Breast Cancer Lymphedema |
| ID | Term |
|---|---|
| D008209 | Lymphedema |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D011183 | Postoperative Complications |
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The affected arms of the patients who received treatment was assessed by indocyanine green lymphography
| 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 | 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) | Baseline and 12 months |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |