Head and Neck Cancer, Radiation Dermatitis, Radiation Toxicity, Radiodermatitis, Skin Diseases
Conditions
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.
Interventions
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.
Sponsors
Jessa Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiodermatitis grading | Day 1 | National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.03 |
| Radiodermatitis severity | Day 1 | Radiation-Induced Skin Reaction Assessment Scale (0- 36, with a higher score correlating with a more severe skin reaction) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life measurement | day 1 | Patient's quality of life will be assessed by using Skindex-16 |
| General satisfaction | Day 35 | Patients' general satisfaction with the skin barrier will be evaluated by using a self-developed questionnaire |
Other
| Measure | Time frame | Description |
|---|---|---|
| Clinical photograph | day 1 | A clinical photograph of the treatment area will be taken |
| Personal and medical information | day 1 | Patient's personal and medical information will be gathered via a patient questionnaire and the patient's medical file |
Countries
Belgium
Outcome results
None listed