3M Cavilon Advanced Skin Protectant for the Prophylaxis of Radiation Dermatitis

Overview

This study observes a liquid skin protectant that is a polymeric-cyanoacrylate solution designed to protect intact or damaged skin due to radiation.

Full Title of Study: “Assessment of 3M Cavilon Advanced Skin Protectant for the Prophylaxis of Radiation Dermatitis in Cancer Patients”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: August 12, 2019

Interventions

  • Other: 3M™ Cavilon™ Advanced Skin Protectant
    • liquid skin protectant on skin to protect from radiation dermatitis

Arms, Groups and Cohorts

  • Cohort A
    • Head and Neck Patients; Photon or Proton Treatment with product
  • Cohort B
    • Hair/skin fold areas (Axilla, Groin, Perineum); Photon or Proton Treatment with product
  • Cohort C
    • Misc. (per Rad Onc Physician); Photon or Proton Therapy with routine skin care

Clinical Trial Outcome Measures

Primary Measures

  • compare radiation dermatitis severity
    • Time Frame: 3 months (+/- 1 month) following the completion of radiation therapy
    • To compare radiation dermatitis severity in irradiated skin protected by a liquid skin protectant (3M™ Cavilon™ Advanced Skin Protectant) that rapidly dries versus uncovered skin (internal control) as determined by a panel.

Participating in This Clinical Trial

Inclusion Criteria

  • Age ≥ 18years. – Patient has initial or recurrent disease – Undergoing external beam radiotherapy at the Mayo Clinic Rochester campus Note: Patients who are undergoing concurrent chemotherapy are eligible – Ability to complete questionnaire(s) by themselves or with assistance – Provide informed written consent – Willing to consent for photography of radiation field – Available to return to Mayo Clinic in within 1 week post treatment for assessment (+/- 7 days). – At risk for developing ≥ grade 2 dermatitis radiation as determined by treating Radiation Oncology clinician – Biologic effective dose of >42 Gy10 as calculated using the web site EQD2.com. Exclusion Criteria:

  • Unable to provide informed consent – Patients with active rash, pre-existing dermatitis, lupus or scleroderma within the treatment area that may make skin assessment for the study difficult – Known history of developing an allergic reaction after using a product containing cyanoacrylate or acrylates – Subject has a medical condition that in the opinion of the investigator should exclude him/her from participating in the study – Subject has been 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)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Investigator Details

  • Lead Sponsor
    • Mayo Clinic
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ivy A. Petersen, M.D., Radiation Oncology Consultant – Mayo Clinic

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