Radiotherapy Related Skin Toxicity: Mepitel® vs. Standard Care in Patients With Locally Advanced Head-and-Neck Cancer

NCT03047174 | Completed Results

• 1 other identifier: RAREST-01
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 2

Brief Summary

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

Head and Neck Neoplasms

Keywords

Head and Neck Neoplasms, Radio(chemo)therapy

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Grade ≥2 Radiation Dermatitis at 50 Gy (Per Protocol Set)

  Radiation dermatitis has been assessed according to the Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.

  at 50 Gy (about 5 weeks)

Secondary Outcomes (11)

• Number of Participants With Grade ≥2 Radiation Dermatitis at 60 Gy (Per Protocol Set)

  at 60 Gy (about 6 weeks)

• Number of Participants With Grade ≥3 Radiation Dermatitis at 50 Gy (Per Protocol Set)

  at 50 Gy (about 5 weeks)

• Number of Participants With Grade ≥3 Radiation Dermatitis at 60 Gy (Per Protocol Set)

  at 60 Gy (about 6 weeks)

• Number of Participants With Grade ≥2 Radiation Dermatitis at 50 Gy (Intention-to-treat Population)

  at 50 Gy (about 5 weeks)

• Number of Participants With Grade ≥2 Radiation Dermatitis at 60 Gy (Intention-to-treat Population)

  at 60 Gy (about 6 weeks)

Study Arms (2)

Arm A: Treatment with Mepitel® Film

EXPERIMENTAL

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.

Other: Mepitel® Film

Arm B: Treatment with Standard Care

ACTIVE COMPARATOR

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.

Other: Standard Care

Interventions

Mepitel® Film OTHER

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.

Arm A: Treatment with Mepitel® Film

Standard Care OTHER

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.

Arm B: Treatment with Standard Care

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Schleswig-Holstein: lead

Study Sites (2)

Department of Radiotherapy (Radiooncology), Christian-Albrechts-Universität zu Kiel and University Medical Center Schleswig-Holstein Campus Kiel

Kiel, Schleswig-Holstein, 24105, Germany

Location

Department of Radiation Oncology, University of Lübeck and University Medical Center Schleswig-Holstein

Lübeck, 23562, Germany

Location

Related Publications (2)

• Rades 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 DERIVED

• Narvaez 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 DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Prof. Dr. med. Dirk Rades
• Organization: Department of Radiation Oncology, University of Lübeck, Germany

dirk.rades@uksh.de

0049 451 500

Study Officials

• Dirk Rades, Prof. Dr.

  Dep. of Radiation Oncology, Univ. of Lübeck, Univ. Med. Center S-H, Germany

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Dr. med.

Study Record Dates

• First Submitted: January 26, 2017
• First Posted: February 8, 2017
• Study Start: May 9, 2017
• Primary Completion: July 16, 2019
• Study Completion: July 16, 2019
• Last Updated: March 24, 2020
• Results First Posted: March 9, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)