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

Breast Cancer Lymphedema Clinical Trial

— FGTBRCL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02981485
• Other study ID #: CZ2015009
• Status: Recruiting
• Phase: Phase 2
• First received: December 1, 2016
• Last updated: December 3, 2016
• Start date: December 2016
• Est. completion date: January 2019

Study information

• Verified date: December 2016
• Source: Peking Union Medical College
• Contact: Minqiang Xin, MD
• Phone: +86 10 88772340
• Email: doctorshin[@]163.com
• Is FDA regulated: No
• Health authority: China: Beijing Municipal Health Bureau
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: January 2019
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

Breast cancer diagnosis regardless of the date of operation and identified unilateral arm lymphedema Stage ? 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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer Lymphedema
• Breast Neoplasms
• Lymphedema

Intervention

Device:
• Fat Grafting
Treatment of breast cancer related lymphedema by fat grafting

Locations

Country	Name	City	State
China	Plastic Surgery Hospital of Chinese Academy of Medical Sciences, Peking Union Medical College	Shijingshan	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	Yes
Secondary	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	No