Feasibility in the Prophylaxis of Radiation Dermatitis Severity

NCT04715386 | Terminated FDA Drug

• 2 other identifiers: 19-007541NCI-2023-00638
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Radiation Dermatitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Patient reported outcomes

  Upon study completion, on average 6 weeks, but will vary per patient

Study Arms (1)

Group 1- StrataXRT

Drug: StrataXRT

Interventions

StrataXRT DRUG

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.

Group 1- StrataXRT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adults with head and neck cancer

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Radiodermatitis

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Radiation Injuries; Wounds and Injuries

Study Officials

• Ivy Petersen, MD

  Mayo Clinic Radiation Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2020
• First Posted: January 20, 2021
• Study Start: June 22, 2020
• Primary Completion: January 30, 2024
• Study Completion: January 30, 2024
• Last Updated: February 9, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)