3M Cavilon Advanced Skin Protectant for the Prophylaxis of Radiation Dermatitis
NCT ID: NCT03546803
Last Updated: 2019-08-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
14 participants
OBSERVATIONAL
2018-02-19
2019-08-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cohort A
Head and Neck Patients; Photon or Proton Treatment with product
3M™ Cavilon™ Advanced Skin Protectant
liquid skin protectant on skin to protect from radiation dermatitis
Cohort B
Hair/skin fold areas (Axilla, Groin, Perineum); Photon or Proton Treatment with product
3M™ Cavilon™ Advanced Skin Protectant
liquid skin protectant on skin to protect from radiation dermatitis
Cohort C
Misc. (per Rad Onc Physician); Photon or Proton Therapy with routine skin care
3M™ Cavilon™ Advanced Skin Protectant
liquid skin protectant on skin to protect from radiation dermatitis
Interventions
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3M™ Cavilon™ Advanced Skin Protectant
liquid skin protectant on skin to protect from radiation dermatitis
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Ivy A. Petersen, M.D.
Radiation Oncology Consultant
Locations
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Mayo Clinic
Rochester, Minnesota, United States
Countries
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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ROR1603
Identifier Type: OTHER
Identifier Source: secondary_id
17-006813
Identifier Type: -
Identifier Source: org_study_id
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