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A Randomized Intra-Patient Controlled Study of StrataXRT ® Versus Current Practice to Prevent and Treat Radiation Dermatitis
This clinical trial studies the effect of StrataXRT in preventing and treating radiation dermatitis in breast cancer or head and neck cancer patients. Radiotherapy is often associated with multiple side effects. These side effects can cause patient injury and make it difficult to complete treatment. For example, radiation dermatitis or skin damage may result in severe skin peeling and skin irritation. Depending on the location of radiation, the skin damage can cause problems and be tough to heal. This trial aims to see whether StrataXRT may help to prevent dermatitis after radiation therapy.
PRIMARY OBJECTIVE: I. Compare efficacy of silicone-based film forming topical gel (StrataXRT) versus (vs.) standard of care skin maintenance. SECONDARY OBJECTIVES: I. Evaluate overall effectiveness of StrataXRT. II. Evaluate post-radiation therapy (RT) recovery time for StrataXRT compared to standard of care. EXPLORATORY OBJECTIVES: I. To assess patient reported outcomes. II. Evaluate cost of StrataXRT for management of radiation dermatitis compared to standard of care skin maintenance. III. Evaluate the reduction in RT interruption/extension of overall duration of receiving RT based on the reduced skin toxicity. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients apply StrataXRT topically to the affected area once or twice daily starting from the first dose of radiation therapy until dermatitis has returned to grade =\< 1. ARM II: Patients receive standard of care including calendula and/or petrolatum-mineral oil-lanolin-ceresin ointment (Aquaphor) applied 2-6 times daily plus hydrogel or silver sulfadiazine (Silvadene) or topical corticosteroids applied twice daily starting from the first dose of radiation therapy until dermatitis has returned to grade =\< 1. After completion of study, patients are followed up at 6 days and 3 weeks post-RT.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
OHSU Knight Cancer Institute
Portland, Oregon, United States
Start Date
January 1, 2024
Primary Completion Date
December 31, 2024
Completion Date
July 1, 2025
Last Updated
May 6, 2024
Calendula Ointment
DRUG
Petrolatum-Mineral Oil-Lanolin-Ceresin Ointment
OTHER
Polyethylene Glycol Hydrogel
OTHER
Silicone-based Film Forming Topical Gel
DRUG
Silver Sulfadiazine
DRUG
Topical Hydrocortisone
DRUG
Lead Sponsor
OHSU Knight Cancer Institute
Collaborators
NCT05372640
NCT04550494
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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