Thermal Imaging to Evaluate Skin Toxicity From Radiotherapy

Not Applicable

Completed

• Conditions: Radiodermatitis; Radiotherapy Side Effect
• Interventions: Diagnostic Test: Thermography

• Registration Number: NCT04013711
• Lead Sponsor: Sunnybrook Health Sciences Centre

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.

Study Timeline

• Study Start: 2018-08-01
• Study First Submitted: 2018-10-15
• Study First Submitted QC: 2019-07-08
• Study First Posted: 2019-07-10
• Primary Completion: 2021-12-30
• Status Verified: 2022-02
• Study Completion: 2022-07-19
• Last Update Submitted: 2023-04-10
• Last Update Posted: 2023-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Thermal Imaging	Thermography	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Sunnybrook Hospital; 🇨🇦 Toronto, Ontario, Canada