Feasibility in the Prophylaxis of Radiation Dermatitis Severity

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

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.

Study Overview

• Status: Terminated
• Conditions: Radiation Dermatitis
• Intervention / Treatment: Drug: StrataXRT

• Study Type: Observational
• Enrollment (Actual): 14

Contacts and Locations

• Study Contact: Name: Kevin Pyfferoen; Phone Number: 507-284-9788; Email: Pyfferoen.Kevin@mayo.edu

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Adults with head and neck cancer

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Group 1- StrataXRT

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Ivy Petersen, MD, Mayo Clinic Radiation Oncology

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2020
• Primary Completion (Actual): January 30, 2024
• Study Completion (Actual): January 30, 2024

Study Registration Dates

• First Submitted: June 17, 2020
• First Submitted That Met QC Criteria: January 14, 2021
• First Posted (Actual): January 20, 2021

Study Record Updates

• Last Update Posted (Estimated): February 9, 2024
• Last Update Submitted That Met QC Criteria: February 7, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Wounds and Injuries; Radiation Injuries; Dermatitis; Radiodermatitis
• Other Study ID Numbers: 19-007541; NCI-2023-00638 (Registry Identifier: CTRP (Clinical Trials Reporting Program))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No