Cosmetic and Functional Outcomes After Breast Conserving Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by National Institute of Oncology, Hungary.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Dr. Zoltan Matrai, National Institute of Oncology, Hungary
ClinicalTrials.gov Identifier:
NCT01496001
First received: December 12, 2011
Last updated: December 29, 2011
Last verified: December 2011
  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: 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 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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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.



Estimated Enrollment: 300
Study Start Date: March 2011
Estimated Primary Completion Date: December 2012 (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

Ages Eligible for Study:   up to 70 Years
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01496001

Locations
Hungary
National Institute of Oncology Recruiting
Budapest, Hungary, 1122
Contact: Zoltan Matrai, M.D.    +3612248600 ext 3302    matraidoc@gmail.com   
Principal Investigator: Zoltan Matrai, M.D.         
Sub-Investigator: Laszlo Toth, M.D., Ph.D., Prof.         
Sub-Investigator: Zoltan Sulyok, M.D.         
Sub-Investigator: Emil Farkas, M.D.         
Sub-Investigator: Andras Szollar, M.D.         
Sub-Investigator: Laszlo Gobor, M.D.         
Sub-Investigator: Gusztav Gulyas, M.D., Ph.D., Prof.         
Sub-Investigator: Csaba Kunos, M.D.         
Sub-Investigator: Csaba Polgar, M.D., Ph.D., Prof.         
Sub-Investigator: Zoltan Zaka, M.D.         
Sub-Investigator: Emoke Mozsa, M.D.         
Sub-Investigator: Maria Godeny, M.D., Ph.D., Prof.         
Sub-Investigator: Maria Bidlek, M.D.         
Sub-Investigator: Eva Szabo, M.D.         
Sub-Investigator: Udvarhelyi Nóra, M.D.         
Sub-Investigator: Rita Losonczy, M.D.         
Principal Investigator: Miklos Kasler, M.D., Ph.D., Prof., D.Sc.         
Sponsors and Collaborators
National Institute of Oncology, Hungary
  More Information

No publications provided

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
Study First Received: December 12, 2011
Last Updated: December 29, 2011
Health Authority: Hungary: Institutional Ethics Committee

Keywords provided by National Institute of Oncology, Hungary:
Early unilateral breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 28, 2014