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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04013711
Other study ID # 187-2018
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 1, 2018
Est. completion date July 19, 2022

Study information

Verified date February 2022
Source Sunnybrook Health Sciences Centre
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date July 19, 2022
Est. primary completion date December 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Thermography
Thermograms will be acquired of both treated and non-treated cancer site for comparison.

Locations

Country Name City State
Canada Sunnybrook Hospital Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
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