The Effects of Radiation in Reconstructed Breasts

Completed

• Conditions: Breast Cancer

• Registration Number: NCT01292772
• Lead Sponsor: Abramson Cancer Center at Penn Medicine

Brief Summary

The primary objective of this study is to use LR imaging to evaluate the effects of adjuvant radiation therapy on reconstructed breasts.

Detailed Description

Immediate breast reconstruction following mastectomy has become an increasingly popular and accepted treatment option among breast cancer patients. This change in practice has resulted in a significant number of patients who undergo radiation therapy after breast reconstruction. Following irradiation, the reconstructed breast often experiences fibrotic contracture, volume loss, altered pigmentation, or some combination thereof, producing an asymmetric and aesthetically compromised result. The effects of radiation on reconstructed breasts as well as the implications that such changes have for timing of reconstructive surgery, post-operative management and surveillance imaging are topics of growing importance in plastic surgery, radiology and surgical oncology.

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2011-02-01
• Study First Submitted QC: 2011-02-09
• Study First Posted: 2011-02-10
• Primary Completion: 2016-12
• Study Completion: 2019-05-05
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-07
• Last Update Posted: 2020-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 12

Inclusion Criteria

• Female patients between 18 and 90 years of age.
• Patients with a diagnosis of unilateral breast cancer who elect to undergo bilateral mastectomy with immediate free flap reconstruction.
• Patients must also have a locally advanced tumor that requires adjuvant radiation therapy following reconstruction.

Exclusion Criteria

• Women who do not undergo immediate, bilateral breast reconstruction using a free flap.
• Women who do not require unilateral, adjuvant radiation therapy
• Women who are pregnant
• Women who have altered renal function, defined as a personal history of diabetic, hypertensive or autoimmune nephropathy and/or on routine preoperative testing are found to have a serum creatinine greater than or equal to 1.3

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reconstructed Breast Volume	up to 1 year after radiation	This will be compared at 2 points: before radiation and 1 year after radiation is completed between the 2 breasts.
Vascular Fibrosis	up to 1 year after radiation	This will be compared at 2 points: before radiation and 1 year after radiation is completed between the 2 breasts.
Dermal Thickness	up to 1 year after radiation	This will be compared at 2 pionts: before radiation and 1 year after radiation is completed between the 2 breasts

Secondary Outcome Measures

Name	Time	Method
Presence of Fat Necrosis in the Breast	up to 1 year after radiation	This will be assessed at 2 points: before radiation and 1 year after radiation is completed between the 2 breasts.
Evidence of Cancer Recurrence	up to 1 year after radiation	This will assessed at 2 points: before radiation and 1 year after radiation is completed between the 2 breasts.
Symmetry	up to 1 year after radiation	This will be assessed at 2 points; before radiation and 1 year after radiation is completed between the 2 breasts.
Hyperpigmentation	up to 1 year after radiation	This will be assessed at 2 points: before radiation and 1 year after radiation is completed between the 2 breasts.
Contracture	up to 1 year after radiation	This will be assessed at 2 points:before radiation and 1 year after radiation is completed between the 2 breasts.
Aesthetic Result	up to 1 year after radiation	This will be assessed at 2 points: before radiation and 1 year after radiation is completed between the 2 breasts.

Trial Locations

Locations (1)

Abramson Cancer Center of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States