Breast deformity after breast-conserving surgery followed by radiation therapy
Conditions
Interventions
1) Adipose tissue collection with inhalation technique
2) Administration of autologous adipose-derived stem cells and adipose tissue with cultured cells
Sponsors
Komuro Yuzou
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Patients who meet all of the following conditions: 1) Female, age 20 years and older 2) Primary breast cancer in one side 3) Anticipate reconstruction for breast deformity after breast-conserving surgery followed by radiation therapy 4) Last surgery for breast cancer more than 1 year prior to enrollment 5) No metastasis, residual or local recurrence, and no evidence of recurrence of cancer 6) Available adipose tissue collection with inhalation technique 7) Signed written informed consent
Exclusion criteria
Exclusion criteria: Patients who meet any of the following conditions: 1) Not enough adipose tissue collection 2) Not controlled infectious diseases 3) Evidence of infection in treatment target area and adipose tissue collection site 4) History of breast augmentation in affected side 5) Presence of any other known malignancy or metastasis 6) Use of anticancer, immunosuppressant, anticoagulant or antiplatelet agents during this research, from first adipose tissue collection to 18-month follow-up 7) Surgery or radiation therapy in treatment target area and adipose tissue collection site during this research, from first adipose tissue collection to 18-month follow-up 8) Considered by investigator due to any other severe condition such as cardiac, lung, liver, kidney, auto-immune, not-controlled diabetes, or drug allergy 9) Pregnant or breast-feeding 10) Smoker or unavailable to quit smoking during this research, from first adipose tissue collection to 18-month follow-up 11) Not appropriate or not consent obtained for general anesthesia 12) Lack of cooperation with the procedures designated for this research 13) Considered as inappropriate for this research for any reason by investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number and Grade (CTCAR v5.0-JCOG) of adverse events related to this research from day 0 to 18 months follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| - Comparison of affected and unaffected breasts in percent change of elasticity measured by ultrasonic elastography - Change in breast subcutaneous tissue thickness and breast volume measured by ultrasonography and breast MRI - Patient reported outcome on health related quality of life evaluated with Breast Q | — |
Countries
Japan
Contacts
Public ContactKiyoko Uno
Teikyo University School of Medicine
Outcome results
None listed