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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Neoplasms
• Intervention / Treatment: Other: Assessment of soft tissue properties; Other: Retest assessment of soft tissue properties

• Study Type: Observational
• Enrollment (Estimated): 90

Contacts and Locations

• Study Contact: Name: An De Groef, Prof.; Phone Number: 003216376668; Email: an.degroef@uantwerpen.be
• Study Contact Backup: Name: Kaat Verbeelen; Email: kaat.verbeelen@uantwerpen.be

Study Locations

• Belgium
  • Antwerpen, Belgium
    • Recruiting
    • Universiteit Antwerpen
    • Contact: Kaat Verbeelen; Email: kaat.verbeelen@uantwerpen.be
    • Contact: An De Groef, Prof.; Email: an.degroef@uantwerpen.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Women with a history of primary breast cancer with and without upper limb dysfunctions and an age- and gender-matched healthy control group

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Women after breast cancer with UL dysfunctions	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
Women after breast cancer without UL dysfunctions	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
Healthy volunteers; age- and gender-matched control group	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	1 week

Collaborators and Investigators

• Sponsor: Universiteit Antwerpen
• Collaborators: KU Leuven

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2023
• Primary Completion (Estimated): May 2, 2025
• Study Completion (Estimated): May 2, 2026

Study Registration Dates

• First Submitted: December 12, 2023
• First Submitted That Met QC Criteria: December 12, 2023
• First Posted (Actual): December 22, 2023

Study Record Updates

• Last Update Posted (Estimated): December 11, 2024
• Last Update Submitted That Met QC Criteria: December 6, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: ultrasound; upper limb dysfunctions
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 2776

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No