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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Breast cancer patients without upper limb dysfunctions (n=30) * 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
Disqualifiers
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
Trial population
Women with a history of primary breast cancer with and without upper limb dysfunctions and an age- and gender-matched healthy control group
Trial design
Cohort
Cross-sectional
Treatments tested in this trial
Assessment of soft tissue properties
Other interventionAssessment of soft tissue properties at the upper limb region with clinical assessments and ultrasound
Retest assessment of soft tissue properties
Other interventionRetest Assessment of soft tissue properties at the upper limb region with clinical assessments and ultrasound
Treatment groups
Trial outcomes
Primary outcomes
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
Reliability of soft tissue composition
Intra- and inter-rater reliability of tissue composition (echo-intensity) measured with 2D ultrasound
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
Secondary outcomes
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
Sponsors and contacts
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Universiteit Antwerpen
Lead sponsor
KU Leuven
Collaborator