Status:
RECRUITING
Reliability and Validity of Ultrasound for the Assessment of Soft Tissue Properties After Breast Cancer Treatment
Lead Sponsor:
Universiteit Antwerpen
Collaborating Sponsors:
KU Leuven
Conditions:
Breast Neoplasms
Eligibility:
FEMALE
18+ years
Brief Summary
After 1 year, more than 50% experience upper limb (UL) complaints after treatment for breast cancer. These complaints are disabling and cause limitations in daily life and this leads to a decrease in ...
Eligibility Criteria
Inclusion
- Breast cancer patients without upper limb dysfunctions (n=30) Inclusion Criteria
- Patients with unilateral primary breast cancer
- Surgery including, either: Mastectomy with axillary lymph node dissection or sentinel lymph node biopsy or breast conserving surgery with axillary lymph node dissection or sentinel lymph node biopsy
- At least 3 months after surgery or radiotherapy in order to take into account wound healing
- Comprehensive of the Dutch language
- QuickDASH score \<15/100
- Exclusion Criteria:
- Bilateral surgery, widespread distance metastases, previous breast surgery
- Diagnosis of neurological or rheumatological condition
- upper limb dysfunctions caused by other reasons
- Breast cancer patients with upper limb dysfunctions (n=30) Inclusion Criteria
- Patients with unilateral primary breast cancer
- Surgery including, either: Mastectomy with axillary lymph node dissection or sentinel lymph node biopsy or breast conserving surgery with axillary lymph node dissection or sentinel lymph node biopsy
- At least 3 months after surgery or radiotherapy in order to take into account wound healing
- Comprehensive of the Dutch language
- QuickDASH score \>15/100
- Exclusion Criteria:
- Bilateral surgery, widespread distance metastases, previous breast surgery
- Diagnosis of neurological or rheumatological condition
- upper limb dysfunctions caused by other reasons
- Healthy volunteers (n=30)
- Inclusion criteria:
- Healthy women (QuickDASH \<15) age-matched with a breast cancer patient from the main study
- Comprehensive of the Dutch language
- Exclusion criteria:
- upper limb dysfunctions
- Diagnosis of neurological or rheumatological condition, diabetes
Exclusion
Key Trial Info
Start Date :
May 2 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 2 2026
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06180642
Start Date
May 2 2023
End Date
May 2 2026
Last Update
December 11 2024
Active Locations (1)
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1
Universiteit Antwerpen
Antwerp, Belgium