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

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.

Study Overview

• Status: Unknown
• Conditions: Breast Cancer Lymphedema
• Intervention / Treatment: Device: Fat Grafting

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Minqiang Xin, MD; Phone Number: +86 10 88772340; Email: doctorshin@163.com
• Study Contact Backup: Name: Chenglong Wang, MD; Phone Number: +86 10 88772076; Email: likexfz@126.com

Study Locations

• China
  • Beijing
    • Shijingshan, Beijing, China, 100144
      • Recruiting
      • Plastic Surgery Hospital of Chinese Academy of Medical Sciences, Peking Union Medical College
      • Contact: Chenglong Wang, MD
      • Principal Investigator: Minqiang Xin, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; Treatment of breast cancer related lymphedema by fat grafting	Device: Fat Grafting; Treatment of breast cancer related lymphedema by fat grafting

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

Collaborators and Investigators

• Sponsor: Peking Union Medical College
• Investigators: Study Director: Jie Luan, MD, Plastic Surgery Hospital of Chinese Academy of Medical Sciences, Peking Union Medical College

Study record dates

Study Major Dates

• Study Start: December 1, 2016
• Primary Completion (Anticipated): January 1, 2018
• Study Completion (Anticipated): January 1, 2019

Study Registration Dates

• First Submitted: December 1, 2016
• First Submitted That Met QC Criteria: December 1, 2016
• First Posted (Estimate): December 5, 2016

Study Record Updates

• Last Update Posted (Estimate): December 6, 2016
• Last Update Submitted That Met QC Criteria: December 3, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: Fat Grafting, Breast Cancer Lymphedema
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Neoplasms; Lymphatic Diseases; Neoplasms by Site; Postoperative Complications; Breast Diseases; Breast Neoplasms; Lymphedema; Breast Cancer Lymphedema
• Other Study ID Numbers: CZ2015009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO