Temperature and Injury in Radiotherapy Radiation Skin Injury

Relationships Between the Changes of Skin Temperature and Radiation Skin Injury

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.

Study Overview

• Status: Unknown
• Conditions: Breast Neoplasm Female; Radiation Toxicity
• Intervention / Treatment: Device: a digital Infrared thermography (FLIR E5 Serial No.63985976）

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 Type: Observational
• Enrollment (Anticipated): 80

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Female patients with a pathologically proven breast cancer receiving three dimensional conformal radiated therapy followed by modified radical mastectomy were eligible for the study. Other inclusion criteria included: age ≥18 years, ECOG PS≤1, normal organ function, no prior radiotherapy, and no concurrent chemotherapy.

Exclusion criteria were as follows: rash or unhealed wound in the radiation field, pregnancy or lactation, and the presence of connective tissue disorder. All the enrolled were giving informed consent.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Thermographic response after radiation	Thermographic change were tested during radiation weekly	during the radiotherapy
temperature changes among the different radiation-dermatitis score	temperature changes among the different radiation-dermatitis score acoording to RTOG score	during the radiotherapy
temperature changes could be used to predict the development of dermatits in the incipient stage	Multiple linear regression analysis was performed to study the influence of various facters on severe dermatits.	during the radiotherapy

Collaborators and Investigators

• Sponsor: Shandong Cancer Hospital and Institute

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2016
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): June 30, 2021

Study Registration Dates

• First Submitted: August 5, 2019
• First Submitted That Met QC Criteria: August 5, 2019
• First Posted (Actual): August 7, 2019

Study Record Updates

• Last Update Posted (Actual): August 12, 2019
• Last Update Submitted That Met QC Criteria: August 8, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: FIR-2015

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes