NCT01496001

Cosmetic and Functional Outcomes After Breast Conserving Surgery

The Effect of Tumor - Breast Volume Ratio on Cosmetic and Functional Outcomes in Breast Conserving Surgery Patients; a Prospective Cohort Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: National Institute of Oncology, Hungary · Academic / Other
• Sex: Female
• Age: 70 Years
• Healthy volunteers: Not accepted

Summary

The initial aesthetic and functional conditions are recorded with the help of the Breast Cancer Treatment Outcome Scale (BCTOS),an international validated questionnaire, and the Breast Cancer Conservative Treatment - cosmetic results (BCCT.core) validated computer software, allowing for comparison. Determination of the initial quality of life is measured with the European Organisation of Research and Treatment of Cancer - Quality of Life Questionnaire number C30-BR23 (EORTC QoL C30-BR23). Patients then undergo surgical treatment according to institutional protocols. Following conventional marking of the orientation of the specimen, it is measured by an analytical scale. Histological examination of the specimen will record the largest diameters, and parameters of the lymph nodes, according to the institutional protocol. On the 4th week following surgery, assuming that wound healing is completed, patients' data are again recorded in BCTOS, BCCT.core and EORTC QoL C30-BR23. A third set of data are gained after completion of adjuvant radiotherapy, on the 8th postoperative month. Magnetic resonance imaging is performed to assess the volume of the contralateral breast. Tumor - breast volume ratio is calculated, and matched up with cosmetic results in each quadrant, threshold value in the quadrants, above of which it is not advisable to perform conventional breast conserving surgery due to poor outcomes.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
PROCEDURE	Lumpectomy, axillary block dissection, breast conserving surgery	Wide excision of primary tumor (using 1 cm surgical margins). Minimally invasive biopsy of the sentinel lymph node.
OTHER	Radiotherapy	Adjuvant radiotherapy carried out by institutional protocols.

Timeline

• Start date: 2011-03-01
• Primary completion: 2015-01-01
• Completion: 2015-01-01
• First posted: 2011-12-21
• Last updated: 2015-10-06

Locations

1 site across 1 country: Hungary