Reliability and Validity of Ultrasound for the Assessment of Soft Tissue Properties After Breast Cancer Treatment
- Conditions
- Breast Neoplasms
- Interventions
- Other: Assessment of soft tissue propertiesOther: Retest assessment of soft tissue properties
- Registration Number
- NCT06180642
- Lead Sponsor
- Universiteit Antwerpen
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 90
Not provided
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Women after breast cancer with UL dysfunctions Assessment of soft tissue properties - Women after breast cancer with UL dysfunctions Retest assessment of soft tissue properties - Women after breast cancer without UL dysfunctions Assessment of soft tissue properties - Women after breast cancer without UL dysfunctions Retest assessment of soft tissue properties - Healthy volunteers Retest assessment of soft tissue properties age- and gender-matched control group Healthy volunteers Assessment of soft tissue properties age- and gender-matched control group
- Primary Outcome Measures
Name Time Method Reliability of soft tissue thickness (mm) 1 week Intra- and inter-rater reliability of thickness (mm) of the skin, fat tissue, breast parenchyma, retromammary fat, and pectoralis major muscle measured with 2D ultrasound
Reliability of soft tissue composition 1 week Intra- and inter-rater reliability of tissue composition (echo-intensity) measured with 2D ultrasound
Reliability of soft tissue elasticity (m/sec) 1 week Intra- and inter-rater reliability of soft tissue elasticity (m/sec) of the pectoralis major muscle and breast measured with shear-wave elastography
- Secondary Outcome Measures
Name Time Method Validity of soft tissue elasticity 1 week Soft tissue elasticity (m/sec) measured with the shear-wave elastography will be compared with the soft tissue index (N/m) measured with the MyotonPro, skin stiffness (N) measure with the SkinFibrometer, severity of tissue toxicity after radiotherapy (0-4) with the Late Radiation Morbidity Scoring Scheme (RTOG) and degree of myofascial adhesions (0-9) measured with the MAP-BC
Trial Locations
- Locations (1)
Universiteit Antwerpen
🇧🇪Antwerpen, Belgium