Feasibility in the Prophylaxis of Radiation Dermatitis Severity

Radiation Dermatitis Clinical Trial

Official title:

Evaluation of Feasibility in the Prophylaxis of Radiation Dermatitis Severity in Cancer Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04715386
• Other study ID #: 19-007541
• Secondary ID: NCI-2023-00638
• Status: Terminated
• Start date: June 22, 2020
• Est. completion date: January 30, 2024

Study information

• Verified date: February 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To compare radiation dermatitis severity in irradiated skin protected by an agent verses uncovered skin based on photographs and track patient reported outcomes with use of the agent.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: January 30, 2024
• Est. primary completion date: January 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18years

• Undergoing external beam radiotherapy for head/neck cancer at Mayo Clinic Rochester campus.

Note: patients undergoing concurrent chemotherapy are eligible.

• Able to provide informed written consent

• Willing to consent for photography of radiation field

• Receiving a dose = 45 Gy and 20 fractions to both the area being treated and the area being used for comparison

Exclusion Criteria:

• Patients with active rash, pre-existing dermatitis, lupus, tattoos, scleroderma or other conditions within the treatment area that may make skin assessment for the study difficult per treating physician discretion.

• Patients with known allergic and other systemic skin diseases even if not directly affecting irradiated fields.

• Any medical condition that in the opinion of the investigator should exclude him/her from participating in the study.

• Enrolled in an investigational study where product was applied to the proposed study site within 30 days of the screening visit

• The skin area affected by radiation requires treatment with a concomitant medication or product (if applicable)

Related Conditions & MeSH terms

• Dermatitis
• Radiation Dermatitis
• Radiodermatitis

Intervention

Drug:
• StrataXRT
Patients will be asked to start topical application of their allocated topical preparation on the area of skin that will be irradiated at the onset of radiation therapy, every day until skin symptoms subside (see patient information pamphlet). Apply twice per day and can be reapplied as skin symptoms arise or as needed. The amount of StrataXRT provided to each patient will be recorded throughout treatment.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare radiation dermatitis severity in irradiated skin protected by an agent versus uncovered skin (internal control) based on photographs.		First day of treatment and last day of radiation therapy (approximately 6 weeks, but will vary per patient) +/- 4 days
Secondary	Patient reported outcomes	Patients will be asked to complete a survey at the end of study that will ask them to provide feedback on the agent used during their treatment.	Upon study completion, on average 6 weeks, but will vary per patient

External Links

•   Mayo Clinic Clinical Trials