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

Primary Purpose

Breast Cancer Lymphedema

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Fat Grafting

About this trial

This is an interventional treatment trial for Breast Cancer Lymphedema focused on measuring Fat Grafting, Breast Cancer Lymphedema

Eligibility Criteria

20 Years - 60 Years (Adult)FemaleDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental

Arm Description

Treatment of breast cancer related lymphedema by fat grafting

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in tissue edema

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

The affected arms of the patients who received treatment was assessed by indocyanine green lymphography

Side effects of treatment

Any side effects of experimental treatment. The patients who received treatment are asked at each visit

Change in quality of life

The patients who received treatment are asked to fill in a questionnaire (EQ-5D- 5 L-questionnaire)

Full Information

NCT ID

NCT02981485

First Posted

December 1, 2016

Last Updated

December 3, 2016

Sponsor

Peking Union Medical College

1. Study Identification

Unique Protocol Identification Number

NCT02981485

Brief Title

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

Acronym

FGTBRCL

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2016

Overall Recruitment Status

Unknown status

Study Start Date

December 2016 (undefined)

Primary Completion Date

January 2018 (Anticipated)

Study Completion Date

January 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Peking Union Medical College

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer Lymphedema

Keywords

Fat Grafting, Breast Cancer Lymphedema

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental

Arm Type

Experimental

Arm Description

Treatment of breast cancer related lymphedema by fat grafting

Intervention Type

Device

Intervention Name(s)

Fat Grafting

Intervention Description

Treatment of breast cancer related lymphedema by fat grafting

Primary Outcome Measure Information:

Title

Change in arm volume

Description

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

Time Frame

Baseline, 3 months, 6months and 12 months

Secondary Outcome Measure Information:

Title

Change in tissue edema

Description

The affected and normal arms of the patients who received treatment are assessed by multi-frequency bioelectrical impedance analysis

Time Frame

Baseline, 3 months, 6months and 12 months

Title

The function of the lymphatic vessel

Description

The affected arms of the patients who received treatment was assessed by indocyanine green lymphography

Time Frame

Baseline, 3 months, 6months and 12 months

Title

Side effects of treatment

Description

Any side effects of experimental treatment. The patients who received treatment are asked at each visit

Time Frame

Baseline, 3 months, 6months and 12 months

Title

Change in quality of life

Description

The patients who received treatment are asked to fill in a questionnaire (EQ-5D- 5 L-questionnaire)

Time Frame

Baseline and 12 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Minqiang Xin, MD

Phone

+86 10 88772340

doctorshin@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Chenglong Wang, MD

Phone

+86 10 88772076

likexfz@126.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jie Luan, MD

Organizational Affiliation

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

Official's Role

Study Director

Facility Information:

Facility Name

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

City

Shijingshan

State/Province

Beijing

ZIP/Postal Code

100144

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Chenglong Wang, MD

First Name & Middle Initial & Last Name & Degree

Minqiang Xin, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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