Fat Grafting Used for the Treatment of Breast Cancer Related Lymphedema in China

Study Overview
=================
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.

Official Title
-----------------
Fat Grafting Used for the Treatment of Breast Cancer Related Lymphedema in China

Conditions
-----------------
Breast Cancer Lymphedema

Intervention / Treatment
-----------------
* Device: Fat Grafting


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Treatment of breast cancer related lymphedema by fat grafting | Device: Fat Grafting<br>* Treatment of breast cancer related lymphedema by fat grafting<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fat Grafting, Breast Cancer Lymphedema