Efficacy of Pulsed Electromagnetic Field Therapy on Acute Radiodermatitis in Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Ultrasonography skin thickness measurement.
研究概览
简要总结
This study aims to evaluate the impact of PEMF on acute radiodermatitis in breast cancer patient and post mastectomy patients.
详细描述
The objective is to understand the effect of PEMF on skin thickness and toxicity after radiotherapy on breast cancer.
The study will include 50 adult female breast cancer undergoing whole-breast irradiation.
This is a randomized, controlled clinical trial will conduct at the outpatient clinic of the Faculty of Physical Therapy, Ahram Canadian University.
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
- Single (Participant)
入排标准
- 年龄范围
- 35 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Breast cancer patients undergoing HF-WBI post-lumpectomy with or without chemotherapy.
- •Unilateral breast cancer
- •Age from 35-55 years.
排除标准
- •Patients had previous irradiation to the same breast.
- •Patients had bilateral breast cancer.
- •Patients had metastatic disease.
- •when the use of bolus material was required to deliver RT.
- •Patients had a pre-existing skin condition or open wound in the treatment area.
结局指标
主要结局
Ultrasonography skin thickness measurement.
时间窗: pre treatment, every two weeks of treatment( total weeks 8 weeks) of treatment for up to 2 months total time.
Ultrasonography was performed before radiotherapy and every two week during radiotherapy, approximately at the same time as skin toxicity assessments. The machine (L15-4 linear-array transducer; Supersonics Aixplorer; Supersonic Imagine; France) and settings were used for all examinations, including gain, depth and frequency. Exams are performed at room temperature of 20-25°C with the patient supine, hands raised above the head and the ultrasound scans are performed by an experienced sonographer. Standard echo gel is used as a couplant between the skin surface and the probe. To ensure good coupling of the probe/skin interface, in addition to the gel, a sound-guiding pad with a size of 130 × 120 × 10 mm was used. During all examinations, special care was taken to avoid any pressure on the skin surface, and the probe is gently applied to the surface
次要结局
- Radiation Therapy Oncology Group (RTOG) SCALE(pre treatment, every two weeks of treatment( total weeks 8 weeks) of treatment for up to 2 months total time.)
研究者
Mahmoud H Mohamed, PhD
Assistant Professor of Physical Therapy
Ahram Canadian University