Effect of Aromatase Inhibitors on Lower Extremity Quantitative Ultrasonographic Measurements and Static and Dynamic Balance Scores in Breast Cancer Patients Using Aromatase Inhibitors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Biodex Balance System
研究概览
简要总结
To evaluate the effects of aromatase inhibitors on lower extremity ultrasonographic measurements, static and dynamic balance scores in breast cancer patients using aromatase inhibitors
详细描述
Breast cancer is the most common cancer in women. 2/3 of breast cancer patients are estrogen and progesterone receptor positive. Tamoxifen or aromatase inhibitors are preferred in most of these patients depending on menopausal status. The increase in the life expectancy of breast cancer patients with medical treatments pushes us to find the cause of the drug side effects encountered during this extended life span and work on preventing/correcting them. It has been proven that aromatase inhibitors cause arthralgia in 40-50% of patients and a loss in bone mineral density, leading to a tendency towards osteoporosis. In this patient group, changes in the tendon and tendon sheath were also observed in ultrasonographic and magnetic resonance imaging and were stated to be the cause of the current symptoms.
In the literature, breast cancer patients have been evaluated in detail in terms of balance, and it has been shown that static and dynamic body balance is worse in this group compared to the control group. Among the breast cancer population, the presence of arthralgia in the patient group using aromatase inhibitors causes an increased risk of falls. In addition, it is thought that lower extremity tendon changes may be a factor in balance and proprioception disorders.
Based on this information, quantitative evaluation of static and dynamic balance in patients is important since there is an increase in the frequency of falls and a tendency to osteoporosis in patients using aromatase inhibitors in breast cancer. No similar study has been found in the literature.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal Woman
- •Between 40-70 ages
- •Stage 1-3 breast cancer
- •Chemotherapy treatment due to breast cancer (Last dosage at least 6 months ago)
- •Using an aromatase inhibitors for at least 1 year for group 1
- •Never using an aromatase inhibitors at all for group 2
- •Volunteers must sign and agree to participate in the study.
排除标准
- •Stage 4 breast cancer
- •Having active chemotherapy
- •Older age patient (over 70 years old)
- •Using of steroid
- •Presence of diabetes mellitus that lasts longer than 3 years or insulin usage
- •Neuropathic complaints
- •Lack of vitamin B12 and thyroid dysfunction
- •Dn4 (dolour neuropathic 4 question) score of 4 and above
- •History of stroke
- •Presence of polyneuropathy diagnosis
- •Medication due to polyneuropathy diagnosis (gabapentin, pregabalin, duloxetine)
- •Loss of motor function in the lower extremity
- •Use of assistive devices for walking
- •Presence of vestibular disorder
- •Presence of cognitive impairment
结局指标
主要结局
Biodex Balance System
时间窗: 21 weeks
We will evaluate the patients with Postural Stability Test protocols in the biodex balance system. Biodex guide will be applied and the results will be compared between two groups.
次要结局
- Brief Pain Inventory(20 weeks)
- Tinetti Balance and Gait Test(21 weeks)
- Fall Efficiency Scale(22 weeks)
- Womac pain index (The Western Ontario and McMaster Universities Arthritis Index)(20 weeks)
- The European Organization for Research and Treatment of Cancer Core module EORTC-QLQ-C30(23 weeks)
- Achilles tendon ultrasound(20 weeks)
- Time Up and Go test (TUG)(6 months)
- Patellar Tendon Ultrasound(22 weeks)
- Quadriceps Tendon Ultrasound(22 weeks)
- The European Organization for Research and Treatment of Cancer breast cancer module (EORTC QLQ-BR23)(6 months)