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

NCT ID: NCT02981485

Last Updated: 2016-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2019-01-31

Brief Summary

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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

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Conditions

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Breast Cancer Lymphedema

Keywords

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Fat Grafting, Breast Cancer Lymphedema

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental

Treatment of breast cancer related lymphedema by fat grafting

Group Type EXPERIMENTAL

Fat Grafting

Intervention Type DEVICE

Treatment of breast cancer related lymphedema by fat grafting

Interventions

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Fat Grafting

Treatment of breast cancer related lymphedema by fat grafting

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Peking Union Medical College

OTHER

Sponsor Role lead

Responsible Party

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Minqiang Xin

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jie Luan, MD

Role: STUDY_DIRECTOR

Plastic Surgery Hospital of Chinese Academy of Medical Sciences, Peking Union Medical College

Locations

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Plastic Surgery Hospital of Chinese Academy of Medical Sciences, Peking Union Medical College

Shijingshan, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Minqiang Xin, MD

Role: CONTACT

Phone: +86 10 88772340

Email: [email protected]

Chenglong Wang, MD

Role: CONTACT

Phone: +86 10 88772076

Email: [email protected]

Facility Contacts

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Chenglong Wang, MD

Role: primary

Other Identifiers

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CZ2015009

Identifier Type: -

Identifier Source: org_study_id