RECRUITINGOBSERVATIONAL

Reliability and Validity of Ultrasound for the Assessment of Soft Tissue Properties After Breast Cancer Treatment

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

About This Trial

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.

Who May Be Eligible (Plain English)

1. 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 Who Should NOT Join This Trial: - Bilateral surgery, widespread distance metastases, previous breast surgery - Diagnosis of neurological or rheumatological condition - upper limb dysfunctions caused by other reasons 2. 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 Who Should NOT Join This Trial: - Bilateral surgery, widespread distance metastases, previous breast surgery - Diagnosis of neurological or rheumatological condition - upper limb dysfunctions caused by other reasons 3. Healthy volunteers (n=30) Who May Qualify: - Healthy women (QuickDASH \<15) age-matched with a breast cancer patient from the main study - Comprehensive of the Dutch language Who Should NOT Join This Trial: - upper limb dysfunctions - Diagnosis of neurological or rheumatological condition, diabetes Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

1. 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 2. 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 3. 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

Treatments Being Tested

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

Locations (1)

Universiteit Antwerpen

Antwerp, Belgium