Radiodermatitis, Radiotherapy Side Effect
Conditions
Brief summary
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
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.
Interventions
DIAGNOSTIC_TESTThermography
Thermograms will be acquired of both treated and non-treated cancer site for comparison.
Sponsors
Sunnybrook Health Sciences Centre
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. 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. 2. Subjects must give appropriate written informed consent prior to participation in the study 3. Subjects must be able and willing to comply and understand the instructions associated with the imaging procedure. 4. Both men and women are eligible for participation 5. Subjects must be at least 18 years of age 6. Subjects must be receiving radiotherapy: 1. adjuvant radiotherapy to the whole breast or chest wall, or; 2. in the case of head and neck treatment, either as definitive treatment or adjuvantly. 7. definitive radiotherapy of the head and neck
Exclusion criteria
1. Subjects with any pre-existing dermatologic abnormalities (open sores, keloids, psoriasis) involving the treated breast or head and neck. 2. Patients with very hairy skin surface (this does not permit measuring the heat output) 3. Subjects with a current or past medical history of connective tissue disease. 4. Subjects who are pregnant or lactating (which usually preclude them from radiotherapy) 5. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Temperature changes in skin during radiotherapy. | 1 year | To measure the temperature changes in skin during each week of radiation therapy and correlate to radiotherapy treatment time. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measure patient-reported toxicity using a validated self-assessment tool (Dermatology Quality of Life Questionnaire) | 1 year | Measure patient-reported symptoms using a validated questionnaire. |
Countries
Canada
Outcome results
None listed