Lymphedema and Skeletal Events in Older Patients Receiving Adjuvant Hormonal and Radiotherarpy in Breast Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 主要终点
- Radiotherapy and arm edema
研究概览
简要总结
study of lymphedema and skeletal events in breast cacer patient receiving adjuvant hormonal therapy and radiothearpy
详细描述
In the United States, it is estimated that there are more than 3.8 million living women has a history of invasive breast cancer, and 268,600 women will be newly diagnosed in 2019. Sixty-four percent of breast cancer survivors (more than 2.4 million women) are ≥ 65 years, whereas 7% are aged younger than 50 years 1.
The most common treatment of early stage (stage I or II) breast cancer is breast-conserving surgery (BCS) with adjuvant radiation therapy (49%) and 34% of patients undergo mastectomy. In contrary, more than two-thirds (68%) of patients with stage III disease undergo mastectomy and most of them receive adjuvant chemotherapy 2.
Some of the most debilitating morbidity after surgery and radiotherapy for breast cancer is related to treatment of the axilla. This includes persistent arm lymphoedema, impaired shoulder mobility and brachial plexopathy. Other exogenous factors have an influence on the risk of radiotherapy-related morbidity as patients' age and obesity 3.
Lymphedema of the arm occurs in 19.9% of women who undergo axillary lymph node dissection and in 5.6% of women who have a sentinel lymph node biopsy 4. Irradiation of the regional lymph nodes may increase the risk, especially among patients receiving axillary lymph node dissection 5.
Early diagnosis of lymphedema is important for optimizing its treatment and preventing its progression 6. Some forms of cancer rehabilitation may reduce the risk and lessen the severity of this condition 7, 8.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 patients with positive diagnosis of stage 1-3 breast cancer and planned AI (anastrazole, letrozole) adjuvant treatment will be included in the study.
- •Patients without known osteoporosis will included in the study, and before AI treatment began.
- •Conventional RT course must be completed (50 Gy/25 fractions, 2 Gy/fraction, 5 days/week).
- •Patients continue to receive adjuvant hormonal treatment (aromatase inhibitors) or adjuvant target therapy (trastuzumab) while monitoring late toxicities
排除标准
- •Male patients
- •Metastatic disease at presentation
- •No definitive surgery
- •Carcinoma in situ or other rare tumors of the breast as phyllodes tumors.
结局指标
主要结局
Radiotherapy and arm edema
时间窗: Baseline
Radiothearpy on axilla my increase arm edema in breast cancer patients measuredvby arm circumference in centimeters
Skeletal events caused by hermonal treatment
时间窗: basline
Hermonal treatment in breast Cancer patients may caused osteoporosis that can be measured by dexascan
次要结局
未报告次要终点
研究者
Ahmed gamal hussein
residant doctor
Assiut University
