Temperature and Injury in Radiotherapy Radiation Skin Injury

• Conditions: Radiation Toxicity; Breast Neoplasm Female

• Registration Number: NCT04047823
• Lead Sponsor: Shandong Cancer Hospital and Institute

Brief 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.

Study Timeline

• Study Start: 2016-10-02
• Status Verified: 2019-08
• Study First Submitted: 2019-08-05
• Study First Submitted QC: 2019-08-05
• Study First Posted: 2019-08-07
• Last Update Submitted: 2019-08-08
• Last Update Posted: 2019-08-12
• Primary Completion: 2020-12-31
• Study Completion: 2021-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

• 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

Exclusion Criteria

• rash or unhealed wound in the radiation field,
• pregnancy or lactation
• the presence of connective tissue disorder

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Thermographic response after radiation	during the radiotherapy	Thermographic change were tested during radiation weekly
temperature changes among the different radiation-dermatitis score	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	during the radiotherapy	Multiple linear regression analysis was performed to study the influence of various facters on severe dermatits.