Fat Grafting Used for the Treatment of Breast Cancer Related Lymphedema in China
FGTBRCL
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Dec 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 1, 2016
CompletedStudy Start
First participant enrolled
December 1, 2016
CompletedFirst Posted
Study publicly available on registry
December 5, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2019
CompletedDecember 6, 2016
December 1, 2016
1.1 years
December 1, 2016
December 3, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Change in tissue edema
Baseline, 3 months, 6months and 12 months
The function of the lymphatic vessel
Baseline, 3 months, 6months and 12 months
Side effects of treatment
Baseline, 3 months, 6months and 12 months
Change in quality of life
Baseline and 12 months
Study Arms (1)
Experimental
EXPERIMENTALTreatment of breast cancer related lymphedema by fat grafting
Interventions
Eligibility Criteria
You may not qualify if:
- Relapse of breast cancer Untreated infection Untreated heart failure Untreated renal failure Untreated deep venous thrombosis in the arm Iodine allergy Pregnancy Psychiatric disorders
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Plastic Surgery Hospital of Chinese Academy of Medical Sciences, Peking Union Medical College
Shijingshan, Beijing Municipality, 100144, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jie Luan, MD
Plastic Surgery Hospital of Chinese Academy of Medical Sciences, Peking Union Medical College
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 1, 2016
First Posted
December 5, 2016
Study Start
December 1, 2016
Primary Completion
January 1, 2018
Study Completion
January 1, 2019
Last Updated
December 6, 2016
Record last verified: 2016-12
Data Sharing
- IPD Sharing
- Will not share