Prospective Randomized control study about the Effect of Postmastectomy Radiation therapy on capsular contracture in patients with implant-based breast reconstructio

Not Applicable

• Conditions: Neoplasms

• Registration Number: KCT0005063
• Lead Sponsor: Yonsei University Health System, Gangnam Severance Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 15 June 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: 114

Inclusion Criteria

Age over 19 years old
Histologically confirmed diagnosis of unilateral breast cancer
Mastectomy (nipple or skin sparing mastectomy) candidate for therapeutic indication and undergoing immediate implant based breast reconstruction
Planned PMRT following immediate breast reconstruction

Exclusion Criteria

Underlying medical condition: for example, (AST or ALT >100U/L, inadequate renal function; eGFR < 30ml/min, congestive heart failure; New York Heart Association III-IV)
Prior history of radiotherapy on the affected side of breast or chest wall before mastectomy
History of a known additional malignancy Note: Participants with melanoma of skin, low grade thyroid cancer are not excluded.
Not able to provide informed consent (Illiterate, foreigners, etc.)

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the frequency of grade 3 or higher contracture development analyzed by using Baker's scale & 2D shear elastography

Secondary Outcome Measures

Name	Time	Method
To compare the patient reported outcome (PRO) using Breast Q questionnaire;To compare the rate of Grade 3 or higher capsular contracture