NCT03743324

Effect of Radiation and Its Timing on Breast Reconstruction in Chinese Patients

A Multi-center Prospective Observational Trial Investigating the Effect of Radiation and Its Timing on Breast Reconstruction in Chinese Patients

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,344 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to investigate the impacts of radiation and the timing of radiation on autologous and prosthetic-based breast reconstruction in Chinese post-mastectomy breast cancer patients. The study aims to optimize the timing for autologous/prosthetic breast reconstruction which delivers the best aesthetic results while maintains low complication rate and best integrates into the comprehensive breast cancer treatment. The study is open to all female breast cancer patients undergoing breast reconstruction in the department of breast reconstruction in Tianjin medical university cancer institute and hospital.

Detailed description

In breast cancer patients, post-operative radiation therapy is an important component in breast cancer management. However, in the context of breast reconstruction, radiation can have adverse effect as it increases the rate of fat necrosis and leads to fibrosis/ capsular contracture in the reconstructed breast mounds. It is therefore necessary to investigate the best timing for breast reconstruction, especially in those patients which post-operative radiation is required, which does not interfere with overall breast cancer treatment while produces the best surgical, aesthetic and psychological outcome. Most studies in this field are retrospective, and studies on Chinese cohort are also rare. This multi-center prospectively designed clinical trial will include several medical centers across China. The investigators will allocate the patients into three arms based on the status and sequence of radiation and breast reconstruction, and will further stratify the groups based on the different approaches of reconstruction (autologous/ prosthetic based). Both objective and subjective (patient oriented) methods will be employed to make evaluations involving surgical, aesthetic, and psychological outcomes.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
PROCEDURE	Immediate Breast reconstruction	Immediate Autologous/prosthetic-based breast reconstruction is performed after mastectomy on the breast that is diagnosed with breast cancer
PROCEDURE	Delayed Breast Reconstruction	Delayed Autologous/prosthetic-based breast reconstruction is performed after mastectomy on the breast that is diagnosed with breast cancer
RADIATION	Radiation	Radiation is performed to the surgical site and complies with the ASCO guidelines on post-mastectomy radiotherapy

Timeline

• Start date: 2019-01-01
• Primary completion: 2022-11-01
• Completion: 2023-04-01
• First posted: 2018-11-16
• Last updated: 2018-11-16