Breast Cancer Lymphedema
Conditions
Keywords
Fat Grafting, Breast Cancer Lymphedema
Brief 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. 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.
Interventions
DEVICEFat Grafting
Treatment of breast cancer related lymphedema by fat grafting
Sponsors
Peking Union Medical College
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
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.
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in arm volume | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in tissue edema | Baseline, 3 months, 6months and 12 months | The affected and normal arms of the patients who received treatment are assessed by multi-frequency bioelectrical impedance analysis |
| The function of the lymphatic vessel | Baseline, 3 months, 6months and 12 months | The affected arms of the patients who received treatment was assessed by indocyanine green lymphography |
| Side effects of treatment | Baseline, 3 months, 6months and 12 months | Any side effects of experimental treatment. The patients who received treatment are asked at each visit |
| Change in quality of life | Baseline and 12 months | The patients who received treatment are asked to fill in a questionnaire (EQ-5D- 5 L-questionnaire) |
Countries
China
Contacts
Primary ContactMinqiang Xin, MD
Backup ContactChenglong Wang, MD
Outcome results
None listed