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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
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.
Ziekenhuis Oost-Limburg
Genk, Limburg, Belgium
Jessa Ziekenhuis
Hasselt, Limburg, Belgium
Radiodermatitis grading
National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.03
Time frame: Day 1
Radiodermatitis grading
National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.03
Time frame: Day 14
Radiodermatitis grading
National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.03
Time frame: Day 20
Radiodermatitis grading
National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.03
Time frame: Day 35
Radiodermatitis grading
National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.03
Time frame: Day 38
Radiodermatitis grading
National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.03
Time frame: Day 47
Radiodermatitis severity
Radiation-Induced Skin Reaction Assessment Scale (0- 36, with a higher score correlating with a more severe skin reaction)
Time frame: Day 1
Radiodermatitis severity
Radiation-Induced Skin Reaction Assessment Scale (0- 36, with a higher score correlating with a more severe skin reaction)
Time frame: Day 14
Radiodermatitis severity
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Radiation-Induced Skin Reaction Assessment Scale (0- 36, with a higher score correlating with a more severe skin reaction)
Time frame: Day 20
Radiodermatitis severity
Radiation-Induced Skin Reaction Assessment Scale (0- 36, with a higher score correlating with a more severe skin reaction)
Time frame: Day 35
Radiodermatitis severity
Radiation-Induced Skin Reaction Assessment Scale (0- 36, with a higher score correlating with a more severe skin reaction)
Time frame: Day 38
Radiodermatitis severity
Radiation-Induced Skin Reaction Assessment Scale (0- 36, with a higher score correlating with a more severe skin reaction)
Time frame: Day 47
Quality of life measurement
Patient's quality of life will be assessed by using Skindex-16
Time frame: day 1
Quality of life measurement
Patient's quality of life will be assessed by using Skindex-16
Time frame: day 14
Quality of life measurement
Patient's quality of life will be assessed by using Skindex-16
Time frame: day 20
Quality of life measurement
Patient's quality of life will be assessed by using Skindex-16
Time frame: day 35
Quality of life measurement
Patient's quality of life will be assessed by using Skindex-16
Time frame: day 38
Quality of life measurement
Patient's quality of life will be assessed by using Skindex-16
Time frame: day 47
General satisfaction
Patients' general satisfaction with the skin barrier will be evaluated by using a self-developed questionnaire
Time frame: Day 35
General satisfaction
Patients' general satisfaction with the skin barrier will be evaluated by using a self-developed questionnaire
Time frame: day 38
General satisfaction
Patients' general satisfaction with the skin barrier will be evaluated by using a self-developed questionnaire
Time frame: day 47