Clinical trial · Observational
Shoulder Disability and Late Symptoms Following Oncoplastic Breast Surgery
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Carcinoma in Situ of the Breast | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- BCS without oncoplastic techniques
- description
- BCS without oncoplastic techniques
- label
- BCS with oncoplastic techniques
- description
- BCS with oncoplastic techniques.
Primary outcomes (1)
- measure
- Shoulder function
- timeFrame
- before and 18 months after surgery
- description
- By measuring passive and active range of movement (ROM) in the shoulder, measuring strength by a dynamometer (IsoForceControl). Estimating Constant Shoulder Score.
Secondary outcomes (1)
- measure
- Quality of life
- timeFrame
- 18 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDHauerslev 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