Using ultrasound to assess soft tissue changes after breast cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate the reliability and validity of conventional 2D ultrasound in assessing soft tissue properties, such as composition and thickness, in breast cancer patients. It focuses on understanding how breast cancer treatment affects upper limb function by examining changes in the soft tissue around the breast and axilla. The study will include two groups of breast cancer patients: those without upper limb dysfunctions and those with such dysfunctions, allowing for a comprehensive analysis of the impact of treatment. Participants will undergo ultrasound assessments to gather objective data on their soft tissue properties.

Why it matters

Who can join: the full rules

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

Where it's running

• Universiteit Antwerpen
  Antwerp, Belgium Recruiting

Study contacts

• Study coordinator: An De Groef, Prof.
• Email: an.degroef@uantwerpen.be
• Phone: 003216376668

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.