Clinical trial NCT04047823: Temperature and Injury in Radiotherapy Radiation Skin Injury
Official title: Relationships Between the Changes of Skin Temperature and Radiation Skin Injury
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Neoplasm Female
Radiation Toxicity
Lead sponsor: Shandong Cancer Hospital and Institute
Sponsor class: OTHER
First posted: 2019-08-07
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Thermographic response after radiation
timeFrame: during the radiotherapy
measure: temperature changes among the different radiation-dermatitis score
timeFrame: during the radiotherapy
measure: temperature changes could be used to predict the development of dermatits in the incipient stage
timeFrame: during the radiotherapy
Secondary outcomes:
Other outcomes:
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