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

Phase 2

• Conditions: Breast Cancer Lymphedema
• Interventions: Device: Fat Grafting

• Registration Number: NCT02981485
• Lead Sponsor: Peking Union Medical College

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-12
• Study Start: 2016-12
• Study First Submitted: 2016-12-01
• Study First Submitted QC: 2016-12-01
• Last Update Submitted: 2016-12-03
• Study First Posted: 2016-12-05
• Last Update Posted: 2016-12-06
• Primary Completion: 2018-01
• Study Completion: 2019-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental	Fat Grafting	Treatment of breast cancer related lymphedema by fat grafting

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Plastic Surgery Hospital of Chinese Academy of Medical Sciences, Peking Union Medical College; 🇨🇳 Shijingshan, Beijing, China