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临床试验/NCT04792840
NCT04792840Unknown不适用

Lymphedema and Skeletal Events in Older Patients Receiving Adjuvant Hormonal and Radiotherarpy in Breast Cancer

Assiut University0 个研究点目标入组 100 人开始时间: 2021年12月1日最近更新:
适应症
相关药物

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed gamal hussein

residant doctor

Assiut University

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