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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04715386
Other study ID # 19-007541
Secondary ID NCI-2023-00638
Status Terminated
Phase
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
See also
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Not yet recruiting NCT02051907 - Clinical Study to Evaluate Safety and Efficacy of KAM1403 Gel to Treat Radiation Dermatitis Phase 2
Completed NCT02839473 - Hydrosorb® Versus Control in the Management of Radio-induced Skin Toxicity: Multicentre Controlled Phase III Randomized Trial Phase 3
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