Reliability and Validity of Ultrasound for the Assessment of Soft Tissue Properties After Breast Cancer Treatment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Assessment of soft tissue properties, Retest assessment of soft tissue properties.
- Who it may be relevant to
- Registry conditions: Breast Neoplasms. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Reliability and Validity of Ultrasound for the Assessment of Structural and Mechanical Properties of Soft Tissues at the Upper Limb Region in Women After Breast Cancer Treatment
Overview
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 the patient's quality of life. The cause of these UL complaints is complex and multifactorial. Due to breast cancer treatment, the structural (tissue composition and volume) and mechanical (tissue stiffness) properties of the soft tissue may change. These changes can occur in the muscle, skin and surrounding fascia and especially in the soft tissue around the breast and axilla where that treatment is localised. Ultrasound with specific 'add-on' techniques can objectively assess these features and provide a picture of their role in UL function after breast cancer. The first aim in this study is to investigate the reliability and validity of conventional 2D ultrasound for 1) soft tissue composition and 2) soft tissue thickness at the level of the breast and upper limb. The reliability and validity of shear wave elastography, a specific complement to conventional 2D ultrasound, to assess tissue stiffness will also be examined.
Interventions
- Other Assessment of soft tissue properties
Assessment of soft tissue properties at the upper limb region with clinical assessments and ultrasound - Other Retest assessment of soft tissue properties
Retest Assessment of soft tissue properties at the upper limb region with clinical assessments and ultrasound
Primary outcome measures
- Reliability of soft tissue thickness (mm) [Time frame: 1 week]
- Reliability of soft tissue composition [Time frame: 1 week]
- Reliability of soft tissue elasticity (m/sec) [Time frame: 1 week]
Secondary outcome measures (1)
- Validity of soft tissue elasticity [Time frame: 1 week]
Eligibility criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Belgium · 1 center
- Universiteit Antwerpen — Antwerp
Identifiers
NCT: NCT06180642 · 2776