Thermal Imaging to Evaluate Skin Toxicity From Radiotherapy

Radiotherapy Side Effect Clinical Trial

Official title:

Quantitative Thermal Imaging to Evaluate Skin Toxicity From Radiation Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04013711
• Other study ID #: 187-2018
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Radiodermatitis
• Radiotherapy Side Effect

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