Shoulder Disability and Late Symptoms Following Oncoplastic Breast Surgery

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2014 by University of Aarhus
Sponsor:
Collaborator:
Danish Cancer Society
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT02159274
First received: June 2, 2014
Last updated: June 5, 2014
Last verified: January 2014
  Purpose

Breast cancer affects a large proportion of Danish women and late morbidity following breast cancer treatment including pain, reduced motility and force of the arm and shoulder, disturbed sensitivity, and lymph edema affects many patients. The risk for such late complications have previously been carefully described by us and others in patients operated by traditional methods, but the follow-up in most of these studies have been rather short , and long time follow-up results are not available. The impact of the new oncoplastic techniques that allows more women to have breast conserving surgery is not known yet. These operations are more extensive and therefore might be accompanied by more complications. The purpose of this study is to give answer to that question.The study includes three parts. First a questionnaire to patients who have breast conserving surgery performed in one of the three breast units in Central Region Denmark. It contains questions regarding arm morbidity, quality of life, comorbidity, and body image. The questionnaire should be filled in preoperatively and 18 months after surgery. The second part consists of an objective evaluation of shoulder and arm function and cosmesis before and after breast conserving surgery with and without oncoplastic techniques. This should be performed at baseline before surgery and 18 months later. The third part is a long time follow-up of patients after breast conserving surgery without oncoplastic techniques. This group of patients is recruited from three breast units in Central Region Denmark. It contains questions regarding arm morbidity, quality of life, comorbidity, and body image. The questionnaire should be filled in preoperatively and 18 months after surgery. The second part consists of an objective evaluation of shoulder and arm function and cosmesis before and after breast conserving surgery with and without oncoplastic techniques. This should be performed at baseline before surgery and 18 months later. The third part is a long time follow-up of patients after breast conserving surgery without oncoplastic techniques. This group of patients is recruited from the cohort in a previous study with 18 months follow-up following breast conserving surgery without oncoplastic technique.


Condition
Breast Cancer
Carcinoma in Situ of the Breast

Study Type: Observational [Patient Registry]
Study Design: Time Perspective: Prospective
Target Follow-Up Duration: 18 Months
Official Title: Shoulder Disability and Late Symptoms Following Oncoplastic Breast Surgery

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Shoulder function [ Time Frame: before and 18 months after surgery ] [ Designated as safety issue: No ]
    By measuring passive and active range of movement (ROM) in the shoulder, measuring strength by a dynamometer (IsoForceControl). Estimating Constant Shoulder Score.


Secondary Outcome Measures:
  • Quality of life [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Comparing EORTC QLQ-c30 and br23 before and 18 months after surgery.


Other Outcome Measures:
  • lymphoedema of the breast and arm [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Estimating arm lympoedema by the water displacement method and breast lymphoedema by clinical evaluation.

  • Cosmetic results [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Comparing cosmetic results by clinical evaluation and photos including breast retraction assessment (BRA)


Estimated Enrollment: 495
Study Start Date: June 2014
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
BCS without oncoplastic techniques
BCS with oncoplastic techniques

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients, who are undergoing breast conserving surgery (including or without oncoplastic surgical techniques) for invasive breast cancer or carcinoma in situ by one of the three breast surgical units in Central Denmark (Viborg, Randers and Aarhus).

And surviving patients from the study by Husted Madsen et. al in 2003-4 ("Sentinel Node Biopsy and Breast Cancer - Aspects of introducing the method in Denmark") are invited to a new evaluation of shoulder and arm function.

Criteria

Inclusion Criteria:

  • Invasive breast cancer or carcinoma in situ
  • Breast conserving surgery including or without oncoplastic surgical techniques

Exclusion Criteria:

  • Patients who are unable to sign an informed consent form
  • Patients above the age og 75 and under the age of 18
  • Patients who have previously been operated in the same or the contralateral breast, shoulder or arm
  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: NCT02159274

Contacts
Contact: Katrine R Hauerslev, MD +45 61106893 katrhaue@rm.dk
Contact: Peer M Christiansen, Professor, DMSci +45 78467508 peerchri@rm.dk

Locations
Denmark
Surgical department P, Aarhus University Hospital Not yet recruiting
Aarhus, Denmark, 8000
Contact: Katrine R Hauerslev, MD    +45 61106893    katrhaue@rm.dk   
Contact: Peer M Christiansen, Professor, DMSci    +45 78467508    peerchri@rm.dk   
Sponsors and Collaborators
University of Aarhus
Danish Cancer Society
Investigators
Principal Investigator: Katrine R. Hauerslev, MD University Hospital of Aarhus
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT02159274     History of Changes
Other Study ID Numbers: KRH-2014, 1-10-72-335-13, 2007-58-0010
Study First Received: June 2, 2014
Last Updated: June 5, 2014
Health Authority: Denmark: Danish Health and Medicines Authority

Keywords provided by University of Aarhus:
Late symptoms
Shoulder function
Cosmetic results
EORTC
Lymphoedema

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoma
Carcinoma in Situ
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on July 22, 2014