Stratpharma AG
The aim of this study is to assess the efficacy and safety of StrataXRT® in comparison to standard of care (defined using the Common Terminology Criteria for Adverse Events [CTCAE], version 5.0) by assessing the severity of inguinal RD in patients receiving elective radiation therapy +/- systemic therapy to the bilateral inguinal nodes.
Radiation Dermatitis
StrataXRT
Aquaphor
Not Applicable
Study Type : | Interventional |
Estimated Enrollment : | 50 participants |
Masking: | Single |
Primary Purpose: | Prevention |
Official Title: | StrataXRT Versus Aquaphor for the Prevention and Management of Radiation Dermatitis in Cancer Patients Receiving Elective Inguinal Radiation Therapy |
Actual Study Start Date : | November 1, 2022 |
Estimated Primary Completion Date : | December 2024 |
Estimated Study Completion Date : | December 2025 |
Arm | Intervention/treatment |
---|---|
Experimental: StrataXRT Studied products will be applied as per the patient information leaflet following manufacturer guidelines to the treatment area. The studied products will be used starting on the first day of radiation therapy. The studied products will be applied twice a day to both the right and left inguinal regions. The studied products will be used daily during the entire course of radiotherapy including on weekends and holidays until at least 4 weeks upon completion of radiation therapy or otherwise until resolution of RD on both sides. |
Device: StrataXRT |
Active Comparator: Aquaphor Studied products will be applied as per the patient information leaflet following manufacturer guidelines to the treatment area. The studied products will be used starting on the first day of radiation therapy. The studied products will be applied twice a day to the entire treatment field. The studied products will be used during the entire course of radiotherapy and for a further 4 weeks upon completion of radiation therapy. |
Drug: Aquaphor |
Ages Eligible for Study: | 18 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Recruiting
Miami Cancer Institute
Miami, Florida, United States, 33176