StrataXRT Versus Aquaphor for the Prevention and Management of Radiation Dermatitis
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.
Conditions:
🦠 Radiation Dermatitis
🗓️ Study Start (Actual) 1 November 2022
🗓️ Primary Completion (Estimated) December 2024
✅ Study Completion (Estimated) December 2025
👥 Enrollment (Estimated) 50
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Miami, Florida, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * At least 18 years of age or older
    • * Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
    • * Life expectancy of at least 6 months
    • * Biopsy-confirmed malignancy without gross nodal involvement of the right or left inguinal regions
    • * Patients will receive elective radiation therapy to bilateral inguinal nodal regions prescribed to 45-50 Gy in 1.8-2 Gy fractions using photon or proton therapy
    • * No known allergy to studied products
    • * Able to give written informed consent, or have written consent given on their behalf
    • * Patients who are able and willing to attend the post-radiation weekly skin assessment appointments
    • * Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation. Abstinence is acceptable if preferred by patient. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.

    Exclusion Criteria:

    • * Patients with gross cancer involvement of either or both inguinal regions.
    • * Patients who have received prior pelvic and/or inguinal radiation therapy.
    • * Patients who cannot apply the studied products to the inguinal region or have it administered to them as required by this study.
    • * Patients with any medical condition such as active connective tissue disorder that predisposes them to an increased risk of potentially severe radiation dermatitis.
    • * Patients with existing rashes or wounds in either inguinal region at baseline.
    • * Planned inguinal dissection within 90 days after completion of radiation therapy on this study.
    • * Female patients who are pregnant or breast feeding.
    • * Patients who are unable to give written informed consent, or are unable to have written consent given on their behalf.
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 20 September 2022
  • First Submitted that Met QC Criteria 20 September 2022
  • First Posted 23 September 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 29 March 2023
  • Last Update Posted 30 March 2023
  • Last Verified March 2023