Radiotherapy Related Skin Toxicity: Mepitel® vs. Standard Care in Patients With Locally Advanced Head-and-Neck Cancer (RAREST-01)
Head and Neck Neoplasms
About this trial
This is an interventional supportive care trial for Head and Neck Neoplasms focused on measuring Head and Neck Neoplasms, Radio(chemo)therapy
Eligibility Criteria
Inclusion Criteria:
- Histologically proven locally advanced squamous cell carcinoma of the head-and-neck (SCCHN)
- Conventionally fractionated (5x2 Gy per week) definitive or adjuvant radio(chemo)therapy
- Age ≥18 years
- Written informed consent
- Capacity of the patient to contract
Exclusion Criteria:
- N3 stage (lymph nodes >6 cm)
- Distant metastases (M1)
- Pregnancy, Lactation
- Treatment with epidermal growth factor receptor (EGFR)-antibodies (either given or planned)
- Expected non-compliance
Sites / Locations
- Department of Radiotherapy (Radiooncology), Christian-Albrechts-Universität zu Kiel and University Medical Center Schleswig-Holstein Campus Kiel
- Department of Radiation Oncology, University of Lübeck and University Medical Center Schleswig-Holstein
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Arm A: Treatment with Mepitel® Film
Arm B: Treatment with Standard Care
Arm A: Mepitel® Film is a gentle, sterile, transparent, breathable film dressing consisting of polyurethane film coated with a special contact layer. The film dressing is supported with a paper frame for ease of application. Mepitel® Film is an ultra thin, transparent, breathable soft silicone film dressing.
Cream: Fatty cream with 2-5% urea is applied to the irradiated skin 3-4 times daily. Mometasone furoate cream: In addition to the fatty cream with 2-5% urea, mometasone furoate cream (solution 0.1%) is applied to the irradiated skin once daily. Mometasone furoate cream is used in the treatment of inflammatory skin disorders. In terms of steroid strength, it is more potent than hydrocortisone, and less potent than dexamethasone. It reduces inflammation by causing several effects such as reversing the activation of inflammatory proteins, activating the secretion of anti-inflammatory proteins, stabilizing cell membranes, and decreasing the influx of inflammatory cells. The exact anti-inflammatory mechanism of action is unknown.