Reliability and Validity of Ultrasound for the Assessment of Soft Tissue Properties After Breast Cancer Treatment (SOFT-TI)

Universiteit Antwerpen

Status: Enrolling

Conditions: Breast Neoplasms

Treatments: Other: Retest assessment of soft tissue properties; Other: Assessment of soft tissue properties

Study type: Observational

Funder types: Other

Identifiers

NCT06180642

2776

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

90 participants in 3 patient groups

Women after breast cancer with UL dysfunctions

Treatment:

Other: Assessment of soft tissue properties

Other: Retest assessment of soft tissue properties

Women after breast cancer without UL dysfunctions

Treatment:

Other: Assessment of soft tissue properties

Other: Retest assessment of soft tissue properties

Healthy volunteers

Description:

age- and gender-matched control group

Treatment:

Other: Assessment of soft tissue properties

Other: Retest assessment of soft tissue properties