A Novel Skin Barrier Protectant for Acute Radiodermatitis (CASP-ORL)

Jessa Hospital

Status: Withdrawn

Conditions: Radiation Toxicity; Radiodermatitis; Skin Diseases; Radiation Dermatitis; Head and Neck Cancer

Treatments: Device: Cavilon Advanced Skin Protectant

Study type: Interventional

Funder types: Other

Identifiers

NCT04593914

20.17-ONCO20.04

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

0 participants in 1 patient group

Cavilon Advanced Skin Protectant

Experimental group

Description:

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.

Treatment:

Device: Cavilon Advanced Skin Protectant