NCT04047823

Temperature and Injury in Radiotherapy Radiation Skin Injury

Relationships Between the Changes of Skin Temperature and Radiation Skin Injury

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 80 (estimated)
• Sponsor: Shandong Cancer Hospital and Institute · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Breast Neoplasm Female
• Radiation Toxicity

Interventions

Type	Name	Description
DEVICE	a digital Infrared thermography (FLIR E5 Serial No.63985976）	Measurements were taken during radiation and additionally two weeks after radiotherapy weekly. Temperature change was measured by thermal infrared imager (FLIR) for 4 test areas within the supraclavicular radiation field and on an opposite non-irradiated area, which was outlined using a specific software package (FLIR Systems 6.3.17227.1001).

Timeline

• Start date: 2016-10-02
• Primary completion: 2020-12-31
• Completion: 2021-06-30
• First posted: 2019-08-07
• Last updated: 2019-08-12

Regulatory

• FDA-regulated device study