Temperature and Injury in Radiotherapy Radiation Skin Injury

Radiation Toxicity Clinical Trial

Official title:

Relationships Between the Changes of Skin Temperature and Radiation Skin Injury

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04047823
• Other study ID #: FIR-2015
• Status: Enrolling by invitation
• Start date: October 2, 2016
• Est. completion date: June 30, 2021

Study information

• Verified date: August 2019
• Source: Shandong Cancer Hospital and Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 80
• Est. completion date: June 30, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasm Female
• Breast Neoplasms
• Radiation Toxicity

Intervention

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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shandong Cancer Hospital and Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Thermographic response after radiation	Thermographic change were tested during radiation weekly	during the radiotherapy
Primary	temperature changes among the different radiation-dermatitis score	temperature changes among the different radiation-dermatitis score acoording to RTOG score	during the radiotherapy
Primary	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