Thermal Imaging to Evaluate Skin Toxicity From Radiotherapy

Study Overview
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Brief Summary
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A significant proportion of patients treated with whole-breast or head and neck radiotherapy will experience skin toxicity, i.e. skin dermatitis, which may lead to erythema, dry desquamation and wet desquamation. It is hypothesized that quantitative thermal imaging can be used to measure radiation-induced skin toxicity.

Detailed Description
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The aim of this study is to use quantitative thermal imaging to evaluate skin toxicity in patients treated with whole-breast or head and neck radiotherapy.

Official Title
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Quantitative Thermal Imaging to Evaluate Skin Toxicity From Radiation Treatment

Conditions
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Radiotherapy Side Effect, Radiodermatitis

Intervention / Treatment
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* Diagnostic Test: Thermography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Biopsy-confirmed diagnosis of breast cancer (Stage 0-III) or head and neck cancer (all subtypes; stage I - IV) according to American Joint Committee on Cancer staging criteria. Subjects must give appropriate written informed consent prior to participation in the study Subjects must be able and willing to comply and understand the instructions associated with the imaging procedure. Both men and women are eligible for participation Subjects must be at least 18 years of age Subjects must be receiving radiotherapy: adjuvant radiotherapy to the whole breast or chest wall, or; in the case of head and neck treatment, either as definitive treatment or adjuvantly. definitive radiotherapy of the head and neck Exclusion Criteria: Subjects with any pre-existing dermatologic abnormalities (open sores, keloids, psoriasis) involving the treated breast or head and neck. Patients with very hairy skin surface (this does not permit measuring the heat output) Subjects with a current or past medical history of connective tissue disease. Subjects who are pregnant or lactating (which usually preclude them from radiotherapy) Subjects, who, in the opinion of the investigator or clinical research coordinator, may not otherwise be appropriate for inclusion into the study, such as significant anxiety, history of musculoskeletal disease which may predispose them to discomfort during the imaging/scanning period.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Thermal Imaging<br>Patients will undergo non-invasive, thermal imaging of their whole breast or head and neck cancer site, during the course of the radiotherapy treatment, at weekly time intervals. | Diagnostic Test: Thermography<br>* Thermograms will be acquired of both treated and non-treated cancer site for comparison.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Temperature changes in skin during radiotherapy. | To measure the temperature changes in skin during each week of radiation therapy and correlate to radiotherapy treatment time. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure patient-reported toxicity using a validated self-assessment tool (Dermatology Quality of Life Questionnaire) | Measure patient-reported symptoms using a validated questionnaire. | 1 year |