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Cosmetic and Functional Outcomes After Breast Conserving Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01496001
First Posted: December 21, 2011
Last Update Posted: October 6, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr. Zoltan Matrai, National Institute of Oncology, Hungary
  Purpose

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.


Condition Intervention
Breast Cancer Procedure: Lumpectomy, axillary block dissection, breast conserving surgery Other: Radiotherapy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: The Effect of Tumor - Breast Volume Ratio on Cosmetic and Functional Outcomes in Breast Conserving Surgery Patients; a Prospective Cohort Study

Resource links provided by NLM:


Further study details as provided by Dr. Zoltan Matrai, National Institute of Oncology, Hungary:

Primary Outcome Measures:
  • Primary outcome is the determination of the critical tumor / breast volume ratio in each quadrant, above of which number breast conserving surgery could not offer adequate cosmetic and functional results. [ Time Frame: 8 months ]

    Data of eligible patients are recorded by the study physicians on a locally developed questionnaire. Digital photos are taken of each patient producing a frontal and two side views. Images are processed by the BCCT.core software (Breast Cancer Conservation Treatment. cosmetic results). Magnetic resonance imaging is implemented and used to calculate breast volume with the help of Amira 5.1 software (Visage Imaging GmbH)trial version.

    Excised tumor is measured by a validated analytical scale.



Secondary Outcome Measures:
  • Assessing the clinical applicability of the Breast Cancer Treatment Outcome Scale (BCTOS). [ Time Frame: 8 months for each patient ]

    Initial cosmetic and functional status is recorded by using the validated BCTOS and the BCCT.core software.

    Patients then undergo surgical procedure according to institutional protocols. On the 4th postoperative week, patients status is recorded by BCTOS, BCTOS.core, EORTC QoL C30-BR23. After adjuvant radiotherapy (according to institutional protocols), in the 8th postoperative month, cosmetic and functional status and quality of life are assessed again with the same methods, and MR images are taken.


  • Assessing the relationship between cosmetic+functional results and quality of life. [ Time Frame: 8 months for each patient ]

    Initial cosmetic and functional status is recorded by using the validated BCTOS and the BCCT.core software.

    Initial quality of life is assessed by the validated EORTC QoL C30-BR23. Patients then undergo surgical procedure according to institutional protocols. On the 4th postoperative week, patients status is recorded by BCTOS, BCTOS.core, EORTC QoL C30-BR23. After adjuvant radiotherapy (according to institutional protocols), in the 8th postoperative month, cosmetic and functional status and quality of life are assessed again with the same methods, and MR images are taken.


  • Assessing the effect of surgical intervention on cosmetic+functional results and quality of life. [ Time Frame: During 8 postoperative months ]

    Initial cosmetic and functional status is recorded by using the validated BCTOS and the BCCT.core software.

    Initial quality of life is assessed by the validated EORTC QoL C30-BR23. Patients then undergo surgical procedure according to institutional protocols. On the 4th postoperative week, patients status is recorded by BCTOS, BCTOS.core, EORTC QoL C30-BR23. After adjuvant radiotherapy (according to institutional protocols), in the 8th postoperative month, cosmetic and functional status and quality of life are assessed again with the same methods, and MR images are taken.


  • Assessing the effect of radiotherapeutical intervention on cosmetic+functional results and quality of life. [ Time Frame: During 8 postoperative months ]

    Initial cosmetic and functional status is recorded by using the validated BCTOS and the BCCT.core software.

    Initial quality of life is assessed by the validated EORTC QoL C30-BR23. Patients then undergo surgical procedure according to institutional protocols. On the 4th postoperative week, patients status is recorded by BCTOS, BCTOS.core, EORTC QoL C30-BR23. After adjuvant radiotherapy (according to institutional protocols), in the 8th postoperative month, cosmetic and functional status and quality of life are assessed again with the same methods, and MR images are taken.


  • Assessing the clinical applicability of the European Organisation of Research and Treatment of Cancer, Quality of Life Questionnaire C30-BR23 (EORTC QoL C30-BR23) validated questionnaire. [ Time Frame: 8 months ]
    Initial quality of life is assessed by the validated EORTC QoL C30-BR23. Patients then undergo surgical procedure according to institutional protocols. On the 4th postoperative week, patients status is recorded by BCTOS, BCTOS.core, EORTC QoL C30-BR23. After adjuvant radiotherapy (according to institutional protocols), in the 8th postoperative month, cosmetic and functional status and quality of life are assessed again with the same methods, and MR images are taken.

  • Assessing the clinical applicability of the BCCT.core software. [ Time Frame: 8 months ]

    Initial cosmetic and functional status is recorded by using the validated BCTOS and the BCCT.core software.

    Patients then undergo surgical procedure according to institutional protocols. On the 4th postoperative week, patients status is recorded by BCTOS, BCTOS.core, EORTC QoL C30-BR23. After adjuvant radiotherapy (according to institutional protocols), in the 8th postoperative month, cosmetic and functional status and quality of life are assessed again with the same methods, and MR images are taken.



Enrollment: 300
Study Start Date: March 2011
Study Completion Date: January 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • early breast cancer
  • unilateral tumor
  • tumor size is less than 3 cm

Exclusion Criteria:

  • age over 70
  • malignant invasive tumor in the past
  • pregnancy
  • previous surgical treatment of the breast or axilla
  • central breast tumor sizing <3 cm
  • a need for mastectomy
  • tumor size >3 cm measured by mammography or physical examination
  • surgical excisions resulting in positive margins
  • surgical or radiotherapeutic complication
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01496001


Locations
Hungary
National Institute of Oncology
Budapest, Hungary, 1122
Sponsors and Collaborators
National Institute of Oncology, Hungary
  More Information

Responsible Party: Dr. Zoltan Matrai, Principal Investigator, National Institute of Oncology, Hungary
ClinicalTrials.gov Identifier: NCT01496001     History of Changes
Other Study ID Numbers: NIO-BCS-QoL
First Submitted: December 12, 2011
First Posted: December 21, 2011
Last Update Posted: October 6, 2015
Last Verified: October 2015

Keywords provided by Dr. Zoltan Matrai, National Institute of Oncology, Hungary:
Early unilateral breast cancer