A Novel Skin Barrier Protectant for Acute Radiodermatitis
- Conditions
- Head and Neck CancerSkin DiseasesRadiodermatitisRadiation ToxicityRadiation Dermatitis
- Interventions
- Device: Cavilon Advanced Skin Protectant
- Registration Number
- NCT04593914
- Lead Sponsor
- Jessa Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cavilon Advanced Skin Protectant Cavilon Advanced Skin Protectant 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.
- Primary Outcome Measures
Name Time Method Radiodermatitis grading Day 47 National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.03
Radiodermatitis severity Day 47 Radiation-Induced Skin Reaction Assessment Scale (0- 36, with a higher score correlating with a more severe skin reaction)
- Secondary Outcome Measures
Name Time Method General satisfaction day 47 Patients' general satisfaction with the skin barrier will be evaluated by using a self-developed questionnaire
Quality of life measurement day 47 Patient's quality of life will be assessed by using Skindex-16
Trial Locations
- Locations (2)
Jessa Ziekenhuis
🇧🇪Hasselt, Limburg, Belgium
Ziekenhuis Oost-Limburg
🇧🇪Genk, Limburg, Belgium