A Novel Skin Barrier Protectant for Acute Radiodermatitis

Study Overview
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Brief Summary
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Acute radiodermatitis (ARD) is a distressing and painful skin reaction that occurs in 95% of the patients undergoing radiotherapy (RT). To date, there is still no general approved guideline for the prevention and management of acute radiodermatitis. The 3M™ Cavilon™ Advanced Skin Protectant is a novel skin barrier protectant that acts as a physical barrier against abrasion, moisture, and irritants. Moreover, it enables an environment for wound healing. The aim of this study is to evaluate the effectiveness of 3M™ Cavilon™ Advanced Skin Protectant in the prevention and management of ARD in patients with head and neck cancer.

Official Title
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Evaluating the Effectiveness of a Novel Skin Barrier Protectant in the Prevention and Management of Acute Radiodermatitis in Patients With Head and Neck Cancer: a Prospective Cohort Study With Historical Controls

Conditions
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Radiodermatitis, Radiation Toxicity, Radiation Dermatitis, Skin Diseases, Head and Neck Cancer

Intervention / Treatment
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* Device: Cavilon Advanced Skin Protectant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of head and neck squamous cell carcinomas (HNSCC) starting in the lip, salivary gland, oral cavity (mouth), nasal cavity (inside the nose), paranasal sinuses, pharynx, or larynx. Scheduled for bilateral neck radiotherapy (>60 Gy) with or without concomitant chemotherapy either as primary or as post-operative treatment to the head and neck region Age ≥ 18 years Able to comply to the study protocol Able to sign written informed consent Signed written informed consent Exclusion Criteria: Previous irradiation to the head and/or neck region Metastatic disease Patients with pre-existing skin rash, ulceration or open wound in the treatment area Patients with known allergic and other systemic skin diseases even when not directly affecting irradiated fields Substance abuse patients or patients with medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results as judged by the investigator Any condition that is unstable or could affect the safety of the patient and their compliance in the study as judged by the investigator Patients using high doses of non-steroidal anti-inflammatory drugs Patients allergic to the ingredients of the 3M™ Cavilon™ Advanced Skin Protectant

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cavilon Advanced Skin Protectant<br>Cavilon Advanced Skin Protectant forms a film barrier intended to protect intact or damaged skin. It is effective in conditions where skin is frequently or continuously exposed to moisture and caustic irritants such as feces, digestive fluids, wound drainage and urine. Cavilon Advanced Skin Protectant also can be used in areas exposed to friction and shear from bedding, clothing, shoes or any other material that would rub against the skin. The skin barrier protectant will be applied on the irradiated skin from the third week of radiotherapy until 1 week after the final radiotherapy session. | Device: Cavilon Advanced Skin Protectant<br>* 3M™ Cavilon™ Advanced Skin Protectant is a polymeric-cyanoacrylate solution intended for the protection of intact or damaged skin. Upon application to skin, the liquid dries rapidly to form a primary long-lasting waterproof, highly durable film barrier. It is elastomeric, adhering to the contours of the skin and providing a uniform film. The film is transparent and possesses good oxygen and moisture vapor permeability. The polymer-cyanoacrylate is dispersed in a non-stinging solvent. The film is colorless, non-cytotoxic and has a low dermatitis potential. The film adheres to dry, moist or wet skin surfaces and remains intact during conditions of continuous or repeated exposure to moisture or caustic irritants. It will wear off the skin and does not require removal.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiodermatitis grading | National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.03 | Day 1 | 
| Radiodermatitis grading | National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.03 | Day 14 | 
| Radiodermatitis grading | National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.03 | Day 20 | 
| Radiodermatitis grading | National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.03 | Day 35 | 
| Radiodermatitis grading | National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.03 | Day 38 | 
| Radiodermatitis grading | National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.03 | Day 47 | 
| Radiodermatitis severity | Radiation-Induced Skin Reaction Assessment Scale (0- 36, with a higher score correlating with a more severe skin reaction) | Day 1 | 
| Radiodermatitis severity | Radiation-Induced Skin Reaction Assessment Scale (0- 36, with a higher score correlating with a more severe skin reaction) | Day 14 | 
| Radiodermatitis severity | Radiation-Induced Skin Reaction Assessment Scale (0- 36, with a higher score correlating with a more severe skin reaction) | Day 20 | 
| Radiodermatitis severity | Radiation-Induced Skin Reaction Assessment Scale (0- 36, with a higher score correlating with a more severe skin reaction) | Day 35 | 
| Radiodermatitis severity | Radiation-Induced Skin Reaction Assessment Scale (0- 36, with a higher score correlating with a more severe skin reaction) | Day 38 | 
| Radiodermatitis severity | Radiation-Induced Skin Reaction Assessment Scale (0- 36, with a higher score correlating with a more severe skin reaction) | Day 47 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life measurement | Patient's quality of life will be assessed by using Skindex-16 | day 1 | 
| Quality of life measurement | Patient's quality of life will be assessed by using Skindex-16 | day 14 | 
| Quality of life measurement | Patient's quality of life will be assessed by using Skindex-16 | day 20 | 
| Quality of life measurement | Patient's quality of life will be assessed by using Skindex-16 | day 35 | 
| Quality of life measurement | Patient's quality of life will be assessed by using Skindex-16 | day 38 | 
| Quality of life measurement | Patient's quality of life will be assessed by using Skindex-16 | day 47 | 
| General satisfaction | Patients' general satisfaction with the skin barrier will be evaluated by using a self-developed questionnaire | Day 35 | 
| General satisfaction | Patients' general satisfaction with the skin barrier will be evaluated by using a self-developed questionnaire | day 38 | 
| General satisfaction | Patients' general satisfaction with the skin barrier will be evaluated by using a self-developed questionnaire | day 47 |