Shoulder Disability and Late Symptoms Following Oncoplastic Breast Surgery

NCT02159274 | Completed DMC

• 3 other identifiers: KRH-20141-10-72-335-132007-58-0010
• Study Type: observational
• Target: 408
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer; Carcinoma in Situ of the Breast

Keywords

Late symptoms; Shoulder function; Cosmetic results; EORTC; Lymphoedema

Outcome Measures

Primary Outcomes (1)

• Shoulder function

  By measuring passive and active range of movement (ROM) in the shoulder, measuring strength by a dynamometer (IsoForceControl). Estimating Constant Shoulder Score.

  before and 18 months after surgery

Secondary Outcomes (1)

• Quality of life

  18 months

Other Outcomes (2)

• lymphoedema of the breast and arm

  18 months

• Cosmetic results

  18 months

Study Arms (2)

BCS without oncoplastic techniques

BCS without oncoplastic techniques

BCS with oncoplastic techniques

BCS with oncoplastic techniques.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead
• Danish Cancer Society: collaborator

Study Sites (1)

Surgical department P, Aarhus University Hospital

Aarhus, 8000, Denmark

Location

Related Publications (1)

• Hauerslev KR, Overgaard J, Damsgaard TE, Hvid HM, Balling E, Fischer L, Christiansen P. Oncoplastic breast surgery versus conventional breast conserving surgery - a prospective follow-up study of subjective loco-regional late morbidity. Acta Oncol. 2021 Jun;60(6):750-759. doi: 10.1080/0284186X.2021.1900907. Epub 2021 Mar 31.

  PMID: 33788646 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Breast Carcinoma In Situ; Lymphedema

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma in Situ; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Katrine R. Hauerslev, MD

  University Hospital of Aarhus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 18 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2014
• First Posted: June 9, 2014
• Study Start: March 1, 2014
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: October 29, 2018

Record last verified: 2018-10

Locations

DK (1)