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

P

Peking Union Medical College

Status and phase

Unknown
Phase 2

Conditions

Breast Cancer Lymphedema

Treatments

Device: Fat Grafting

Study type

Interventional

Funder types

Other

Identifiers

NCT02981485
CZ2015009

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

Female

Ages

20 to 60 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

Experimental
Experimental group
Description:
Treatment of breast cancer related lymphedema by fat grafting
Treatment:
Device: Fat Grafting

Trial contacts and locations

1

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Central trial contact

Chenglong Wang, MD; Minqiang Xin, MD

Data sourced from clinicaltrials.gov

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