Temperature and Injury in Radiotherapy Radiation Skin Injury

NCT ID: NCT04047823

Last Updated: 2019-08-12

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-10-02
• Study Completion Date: 2021-06-30

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.

Conditions

Breast Neoplasm Female; Radiation Toxicity

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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).

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Shandong Cancer Hospital and Institute

OTHER

Sponsor Role: lead

Responsible Party

Han Xi Zhao

M.D.Ph.D

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

FIR-2015

Identifier Type: -

Identifier Source: org_study_id