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| Name | Class |
|---|---|
| KU Leuven | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Women after breast cancer with UL dysfunctions |
| ||
| Women after breast cancer without UL dysfunctions |
| ||
| Healthy volunteers | age- and gender-matched control group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Assessment of soft tissue properties | Other | Assessment of soft tissue properties at the upper limb region with clinical assessments and ultrasound |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reliability of soft tissue thickness (mm) | 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 | 1 week |
| Reliability of soft tissue composition | Intra- and inter-rater reliability of tissue composition (echo-intensity) measured with 2D ultrasound | 1 week |
| Reliability of soft tissue elasticity (m/sec) | Intra- and inter-rater reliability of soft tissue elasticity (m/sec) of the pectoralis major muscle and breast measured with shear-wave elastography | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Validity of soft tissue elasticity | 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 |
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Breast cancer patients without upper limb dysfunctions (n=30) Inclusion Criteria
Exclusion Criteria:
Breast cancer patients with upper limb dysfunctions (n=30) Inclusion Criteria
Exclusion Criteria:
Healthy volunteers (n=30)
Inclusion criteria:
Exclusion criteria:
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Women with history of primary breast cancer
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Women with a history of primary breast cancer with and without upper limb dysfunctions and an age- and gender-matched healthy control group
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| An De Groef, Prof. | Contact | 003216376668 | an.degroef@uantwerpen.be | |
| Kaat Verbeelen | Contact | kaat.verbeelen@uantwerpen.be |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universiteit Antwerpen | Recruiting | Antwerp | Belgium |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Retest assessment of soft tissue properties | Other | Retest Assessment of soft tissue properties at the upper limb region with clinical assessments and ultrasound |
|
| 1 week |
| D017437 |
| Skin and Connective Tissue Diseases |