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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Reliability of soft tissue thickness (mm)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •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
- •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
- •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
结局指标
主要结局
Reliability of soft tissue thickness (mm)
时间窗: 1 week
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
时间窗: 1 week
Intra- and inter-rater reliability of tissue composition (echo-intensity) measured with 2D ultrasound
Reliability of soft tissue elasticity (m/sec)
时间窗: 1 week
Intra- and inter-rater reliability of soft tissue elasticity (m/sec) of the pectoralis major muscle and breast measured with shear-wave elastography
次要结局
- Validity of soft tissue elasticity(1 week)
研究者
An De Groef
Professor
Universiteit Antwerpen