Relationships Between the Changes of Skin Temperature and Radiation Skin Injury
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 主要终点
- Thermographic response after radiation
研究概览
简要总结
the main purpose of the present study was threefold: (1) to describe the thermographic response after radiation; (2) to investigate whether there was a significant temperature change over time and among the different radiation-dermatitis score; and (3) to test if temperature change could be used to predict the development of radiation-induced skin injury in the incipient stage.
详细描述
Radiation skin injury (RSI) is a frequent adverse reaction reported encountered by patients undergoing radiotherapy, occurring in about 87%-95% of irradiated patients and is characterized by swelling, redness, pigmentation, ulceration, fibrosis, pain, warmth, burning and itching of the skin. RSI has an effect on the level of discomfort experienced and the quality of life of patients, and may require interfering with radiation schedule and complex surgical reconstruction especially when combined with molecular targeted therapy. However, evaluation of RSI is not straightforward. There is no standard instrument for objective clinical evaluation of the severity of radiation skin injury.
Previous studies have shown that radiation leads to the development of cutaneous vasculature and generation of an inflammatory response, which will increased skin temperature. The skin temperature change due to laser or thermal injury has been measured in many studies with temperature and time as predictors of skin damage.
The most frequent method of skin temperature measurement has been the Infrared thermography. Consequently, the changes in the difference of skin temperature (DST) may be used as an objective, quantitative, and functional surrogate measure to determine and predict RSI.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •a pathologically proven breast cancer receiving three dimensional conformal radiated therapy followed by modified radical mastectomy
- •ECOG PS≤1
- •normal organ function
- •no prior radiotherapy
- •no concurrent chemotherapy
排除标准
- •rash or unhealed wound in the radiation field,
- •pregnancy or lactation
- •the presence of connective tissue disorder
结局指标
主要结局
Thermographic response after radiation
时间窗: during the radiotherapy
Thermographic change were tested during radiation weekly
temperature changes among the different radiation-dermatitis score
时间窗: during the radiotherapy
temperature changes among the different radiation-dermatitis score acoording to RTOG score
temperature changes could be used to predict the development of dermatits in the incipient stage
时间窗: during the radiotherapy
Multiple linear regression analysis was performed to study the influence of various facters on severe dermatits.
次要结局
未报告次要终点
研究者
Han Xi Zhao
M.D.Ph.D
Shandong Cancer Hospital and Institute