Effect of Bra Use During Radiotherapy for Breast Cancer Radiotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- The reproducibility of breast shape through cross-correlation values, both with and without the use of a bra
研究概览
简要总结
This prospective randomized study investigated the reproducibility of breast shape, radiation dose irradiated to the lungs, heart, dose distribution, patient satisfaction, and treatment toxicity when wearing and not wearing a bra during radiotherapy for patients with breast cancer.
详细描述
Post-surgery radiotherapy to the breast is standard treatment after breast-conserving surgery in patients with breast cancer. In order to apply the latest radiation therapy technologies, such as intensity-modulated radiotherapy, it is important to maintain the correct posture. However, due to the nature of the breast made of soft tissue, it is difficult to maintain the same breast shape during each treatment. This is especially difficult for large, ptotic breasts. Accordingly, we developed a bra for breast cancer patients in order to perform accurate radiotherapy. It was designed to fix the breast using bands in various directions so that its shape and position can be fixed during radiation treatment.
This is a prospective, randomized controlled study to evaluate the effects of using a bra for breast cancer patients on the reproducibility of breast shape, radiation dose irradiated to the lungs, heart, dose distribution, patient satisfaction, and treatment toxicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Test group: Group wearing a radiotherapy bra / Control group: Group not wearing a radiotherapy bra -Allocation: Random -Blinding: None -Time: Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically confirmed invasive breast cancer or ductal carcinoma in situ
- •Patients eligible for whole breast irradiation after partial mastectomy
- •Adults over 20 years old
- •Patients with good overall performance (ECOG PS 0-1)
排除标准
- •Recurrent breast cancer patients
- •Patients who have previously received radiation therapy to the ipsilateral breast
- •Patients who underwent breast reconstruction
- •Bilateral breast cancer
- •Patients with skin diseases such as contact dermatitis
结局指标
主要结局
The reproducibility of breast shape through cross-correlation values, both with and without the use of a bra
时间窗: During the radiotherapy, an average of 1 month
Evaluating the reproducibility of breast shape through cross-correlation values in cone-beam CT and planning CT matching. This study involves comparing groups of patients wearing and not wearing a bra
次要结局
- Radiation dosimetric evaluation(at the time of completion of radiotherapy)
- Patient satisfaction assessment(at the time of completion of radiotherapy)
- Assessment of treatment toxicity(at 6 months and 12 months after the radiotherapy)
研究者
Hwa Kyung Byun
professor
Yonsei University