We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study is currently recruiting participants.
Verified December 2016 by Minqiang Xin, Peking Union Medical College
Sponsor:
ClinicalTrials.gov Identifier:
NCT02981485
First Posted: December 5, 2016
Last Update Posted: December 6, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Minqiang Xin, Peking Union Medical College
  Purpose
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.

Condition Intervention Phase
Breast Cancer Lymphedema Device: Fat Grafting Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Fat Grafting Used for the Treatment of Breast Cancer Related Lymphedema in China

Resource links provided by NLM:


Further study details as provided by Minqiang Xin, Peking Union Medical College:

Primary Outcome Measures:
  • Change in arm volume [ Time Frame: Baseline, 3 months, 6months and 12 months ]
    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 [ Time Frame: Baseline, 3 months, 6months and 12 months ]
    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 [ Time Frame: Baseline, 3 months, 6months and 12 months ]
    The affected arms of the patients who received treatment was assessed by indocyanine green lymphography

  • Side effects of treatment [ Time Frame: Baseline, 3 months, 6months and 12 months ]
    Any side effects of experimental treatment. The patients who received treatment are asked at each visit

  • Change in quality of life [ Time Frame: Baseline and 12 months ]
    The patients who received treatment are asked to fill in a questionnaire (EQ-5D- 5 L-questionnaire)


Estimated Enrollment: 30
Study Start Date: December 2016
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental
Treatment of breast cancer related lymphedema by fat grafting
Device: Fat Grafting
Treatment of breast cancer related lymphedema by fat grafting

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02981485


Contacts
Contact: Minqiang Xin, MD +86 10 88772340 doctorshin@163.com
Contact: Chenglong Wang, MD +86 10 88772076 likexfz@126.com

Locations
China, Beijing
Plastic Surgery Hospital of Chinese Academy of Medical Sciences, Peking Union Medical College Recruiting
Shijingshan, Beijing, China, 100144
Contact: Chenglong Wang, MD         
Principal Investigator: Minqiang Xin, MD         
Sponsors and Collaborators
Peking Union Medical College
Investigators
Study Director: Jie Luan, MD Plastic Surgery Hospital of Chinese Academy of Medical Sciences, Peking Union Medical College
  More Information

Responsible Party: Minqiang Xin, Principal Investigator, Peking Union Medical College
ClinicalTrials.gov Identifier: NCT02981485     History of Changes
Other Study ID Numbers: CZ2015009
First Submitted: December 1, 2016
First Posted: December 5, 2016
Last Update Posted: December 6, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Minqiang Xin, Peking Union Medical College:
Fat Grafting, Breast Cancer Lymphedema

Additional relevant MeSH terms:
Breast Neoplasms
Lymphedema
Breast Cancer Lymphedema
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Lymphatic Diseases
Postoperative Complications
Pathologic Processes