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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorUniversiteit Antwerpen

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

Qualifiers

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 design

Treatments tested in this trial

  • Assessment of soft tissue properties
  • Retest assessment of soft tissue properties

Treatment groups

90 Participants
are divided into 3 treatment groups

Sponsors and collaborators