Clinical trial · Interventional
Radiotherapy Related Skin Toxicity: Mepitel® vs. Standard Care in Patients With Locally Advanced Head-and-Neck Cancer
Radiotherapy Related Skin Toxicity: Mepitel® Film vs. Standard Care in Patients With Locally Advanced Head-and-Neck Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aim for the present study named RAREST (RAdiotherapy RElated Skin Toxicity) is to compare the new dressing with the standard skin care. 168 patients receiving radiotherapy alone or radiochemotherapy for locally advanced head-and-neck cancer will be included. The primary aim is to investigate the rate of patients experiencing severe, stressful radiation dermatitis. The skin status will daily be inspected and assessed by specially trained doctors and nursing staff. It is expected that the new self-adhesive dressing is superior to standard care with respect to prevention of grade ≥2 radiation dermatitis in patients receiving radiotherapy or radio(chemo)therapy for a head-and-neck tumor. Thus, the dressing would be well qualified to become a new standard procedure at the skin care of patients with a head-neck tumor.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Neoplasms | Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mepitel® Film | Other | — | UNRESOLVED |
| Standard Care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A: Treatment with Mepitel® Film
- description
- 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.
- interventionNames
- Other: Mepitel® Film
- type
- ACTIVE_COMPARATOR
- label
- Arm B: Treatment with Standard Care
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDRades D, Narvaez CA, Splettstosser L, Domer C, Setter C, Idel C, Ribbat-Idel J, Perner S, Bartscht T, Olbrich D, Schild SE, Carl J. A randomized trial (RAREST-01) comparing Mepitel(R) Film and standard care for prevention of radiation dermatitis in patients irradiated for locally advanced squamous cell carcinoma of the head-and-neck (SCCHN). Radiother Oncol. 2019 Oct;139:79-82. doi: 10.1016/j.radonc.2019.07.023. Epub 2019 Aug 17. PMID 31431372
- DERIVEDNarvaez C, Doemer C, Idel C, Setter C, Olbrich D, Ujmajuridze Z, Carl JH, Rades D. Radiotherapy related skin toxicity (RAREST-01): Mepitel(R) film versus standard care in patients with locally advanced head-and-neck cancer. BMC Cancer. 2018 Feb 17;18(1):197. doi: 10.1186/s12885-018-4119-x. PMID 29454311