Prospective Outcomes After Reconstruction and Radiotherapy for Breast Cancer

Radiotherapy Clinical Trial

Official title:

Prospective Outcomes After Reconstruction and Radiotherapy for Breast Cancer

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00845078
• Other study ID #: PRO07120002
• Status: Withdrawn
• Phase: N/A
• First received: February 13, 2009
• Last updated: April 25, 2017
• Start date: December 2008

Study information

• Verified date: February 2009
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study examines the aesthetic outcomes of breast reconstruction after mastectomy for breast cancer in patients who require post-mastectomy radiation treatment. Patients will undergo autologous tissue breast reconstruction either in immediate fashion, prior to radiation treatment, or in delayed fashion, after radiation treatment. Both approaches are acceptable and are practiced clinically. this will be an observational prospective cohort study.

The investigators hypothesize that immediate autologous reconstruction patients who undergo subsequent radiation therapy have equivalent aesthetic outcome when compared to those in whom reconstruction is delayed until after radiation, with the additional benefit of avoiding the psychological side effects of breast amputation.

Description:

Neo-adjuvant or adjuvant chemo-radiation remains one of the pillars for breast cancer treatment. (1, 2) Administration of radiation before or after autologous soft tissue reconstruction has being shown to alter the aesthetics of the new breast. (3-7) Currently, the optimal timing for autologous breast reconstruction in patients who need postmastectomy radiotherapy remains in debate between surgeons. (8) Various studies have tried to address this problem. However, most of them have been retrospective studies (3, 7, 9) and the prospective ones have not have enough patients, have mixed population of patients or the radiation protocols have not been normalized. (5, 6, 10)

We hypothesize that immediate autologous reconstruction patients who undergo subsequent radiation therapy have equivalent aesthetic outcome when compared to those in whom reconstruction is delayed until after radiation, with the additional benefit of avoiding the psychological side effects of breast amputation.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Breast cancer requiring mastectomy and post-mastectomy radiation

• Desire for breast reconstruction after mastectomy

Exclusion Criteria:

• Inflammatory breast cancer

• Age < 18 years old

• No desire for breast reconstruction

• Women without need for postmastectomy radiation

Related Conditions & MeSH terms

• Aesthetics
• Breast
• Radiotherapy
• Surgical Reconstruction
• Treatment Outcome

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

References & Publications (5)

Edsander-Nord A, Brandberg Y, Wickman M. Quality of life, patients' satisfaction, and aesthetic outcome after pedicled or free TRAM flap breast surgery. Plast Reconstr Surg. 2001 Apr 15;107(5):1142-53; discussion 1154-5. — View Citation

Kroll SS, Coffey JA Jr, Winn RJ, Schusterman MA. A comparison of factors affecting aesthetic outcomes of TRAM flap breast reconstructions. Plast Reconstr Surg. 1995 Sep;96(4):860-4. — View Citation

Kroll SS, Robb GL, Reece GP, Miller MJ, Evans GR, Baldwin BJ, Wang B, Schusterman MA. Does prior irradiation increase the risk of total or partial free-flap loss? J Reconstr Microsurg. 1998 May;14(4):263-8. — View Citation

Tran NV, Chang DW, Gupta A, Kroll SS, Robb GL. Comparison of immediate and delayed free TRAM flap breast reconstruction in patients receiving postmastectomy radiation therapy. Plast Reconstr Surg. 2001 Jul;108(1):78-82. — View Citation

Tran NV, Evans GR, Kroll SS, Baldwin BJ, Miller MJ, Reece GP, Robb GL. Postoperative adjuvant irradiation: effects on tranverse rectus abdominis muscle flap breast reconstruction. Plast Reconstr Surg. 2000 Aug;106(2):313-7; discussion 318-20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aesthetic breast scores		preoperative, 1 month, 6 months, 12 months, 24 months
Secondary	Quality of life (SF36)		preoperative, 1 month, 6 months, 12 months, 24 months
Secondary	Patient Breast aesthetic perception (BR23)		preoperative, 1 month, 6 months, 12 months, 24 months