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Temperature and Injury in Radiotherapy Radiation Skin Injury

Relationships Between the Changes of Skin Temperature and Radiation Skin Injury

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04047823
Enrollment
80
Registered
2019-08-07
Start date
2016-10-02
Completion date
2021-06-30
Last updated
2019-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Neoplasm Female, Radiation Toxicity

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.

Interventions

DEVICEa 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).

Sponsors

Shandong Cancer Hospital and Institute
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
temperature changes could be used to predict the development of dermatits in the incipient stageduring the radiotherapyMultiple linear regression analysis was performed to study the influence of various facters on severe dermatits.
Thermographic response after radiationduring the radiotherapyThermographic change were tested during radiation weekly
temperature changes among the different radiation-dermatitis scoreduring the radiotherapytemperature changes among the different radiation-dermatitis score acoording to RTOG score

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026