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Radiotherapy Related Skin Toxicity: Mepitel® vs. Standard Care in Patients With Locally Advanced Head-and-Neck Cancer (RAREST-01)

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ClinicalTrials.gov Identifier: NCT03047174
Recruitment Status : Recruiting
First Posted : February 8, 2017
Last Update Posted : July 11, 2017
Sponsor:
Information provided by (Responsible Party):
Prof. Dirk Rades, MD, University of Schleswig-Holstein

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.


Condition or disease Intervention/treatment Phase
Head and Neck Neoplasms Other: Mepitel® Film Other: Standard Care Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 168 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Radiotherapy Related Skin Toxicity: Mepitel® Film vs. Standard Care in Patients With Locally Advanced Head-and-Neck Cancer
Actual Study Start Date : May 9, 2017
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm A: Treatment with Mepitel® Film

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
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.

Active Comparator: Arm B: Treatment with Standard Care

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

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.





Primary Outcome Measures :
  1. Superiority in prevention of grade ≥2 radiation dermatitis [ Time Frame: End of Radio(chemo)therapy up to 50 Gy (about 5 weeks) ]
    Radiation dermatitis will be assessed according to CTCAE v4.03.


Secondary Outcome Measures :
  1. Time to grade 2 radiation dermatitis until 50 Gy of radiotherapy [ Time Frame: End of Radio(chemo)therapy up to 50 Gy (about 5 weeks) ]
    Time to radiation dermatitis will be measured in days of radiotherapy.

  2. Rate of patients experiencing grade ≥2 radiation dermatitis during radio(chemo)therapy [ Time Frame: End of Radio(chemo)therapy up to 50 Gy (about 5 weeks) ]
    Radiation dermatitis grade ≥2 will be assessed according to CTCAE v4.03.

  3. Rate of patients experiencing grade ≥3 skin toxicity during radio(chemo)therapy [ Time Frame: weekly during radiotherapy up to 50 Gy (about 5 weeks) ]
    Grade ≥3 skin toxicity will be assessed according to CTCAE v4.03.

  4. Adverse Events [ Time Frame: daily during radiotherapy for the first 5 weeks, at the end of radiotherapy (after 6-7 weeks), and at weeks 1 + 3 following radiotherapy, i.e. for a total of 9-10 weeks ]
    Adverse events will be assessed according to CTCAE v4.03.

  5. Quality of life: Evaluation prior to radiotherapy [ Time Frame: Prior to radiotherapy, at the end of radiotherapy weeks 3 + 5, and at 3 weeks following radiotherapy ]
    Quality of life will be assessed with the EORTC QLQ-C30 and EORTC QLQ-H&N35 questionnaires.

  6. Pain (Radiation fields) [ Time Frame: daily during radiotherapy for the first 5 weeks, at the end of radiotherapy (after 6-7 weeks), and at weeks 1 + 3 following radiotherapy, i.e. for a total of 9-10 weeks ]
    The pain score will be assessed by using a numeric self rating scale from 0 (no pain) to 10 (maximum pain) points. An increase of pain by 2 points will be considered relevant. The number of participants with an increase of the pain score of >=2 points will be assessed.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03047174


Contacts
Contact: Dirk Rades, Prof. Dr. +49-451-500-45400 dirk.rades@uksh.de
Contact: Kirsten Hakelberg, Dr. med. +49-451-500-45410 kirsten.hakelberg@uksh.de

Locations
Germany
Department of Radiotherapy (Radiooncology), Christian-Albrechts-Universität zu Kiel and University Medical Center Schleswig-Holstein Campus Kiel Recruiting
Kiel, Schleswig-Holstein, Germany, 24105
Contact: Jürgen Dunst, Prof. Dr.    +4943150026500    juergen.dunst@uksh.de   
Contact: Schmalz Claudia, Dr. med.    +4943150026511    claudia.schmalz@uksh.de   
Principal Investigator: Jürgen Dunst, Prof. Dr.         
Sub-Investigator: Claudia Schmalz, Dr. med.         
Sub-Investigator: Melica Reutemann, Dr. med.         
Sub-Investigator: Rene Baumann, Dr. med.         
Sub-Investigator: Florian Pyschny         
Sub-Investigator: Cornelia Setter, Dr. med.         
Department of Radiation Oncology, University of Lübeck and University Medical Center Schleswig-Holstein Recruiting
Lubeck, Germany, 23562
Contact: Dirk Rades, Prof. Dr.    +49-451-500-45400    dirk.rades@uksh.de   
Contact: Kirsten Hakelberg, Dr. med.    +49-451-500-45410    kirsten.hakelberg@uksh.de   
Principal Investigator: Dirk Rades, Prof. Dr.         
Sub-Investigator: Kirsten Hakelberg, Dr. med.         
Sub-Investigator: Carlos A Narvaez         
Sub-Investigator: Annika Panzner, Dr. med.         
Sub-Investigator: Michael von Staden, Dr. med.         
Sub-Investigator: Christian Staackmann         
Sub-Investigator: Liesa Dziggel, Dr. med.         
Sub-Investigator: Tobias Schröder         
Sub-Investigator: Jan-Dirk Küter, Dr. med.         
Sub-Investigator: Natalie Graen         
Sub-Investigator: Laura Motisi, Dr. med.         
Sub-Investigator: Maike Radtke, Dr. med.         
Sponsors and Collaborators
University of Schleswig-Holstein
Investigators
Principal Investigator: Dirk Rades, Prof. Dr. Department of Radiation Oncology, University of Lübeck, University Medical Center Schleswig-Holstein Campus Lübeck (Germany), Ratzeburger Allee 160, 23538 Lübeck

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Dirk Rades, MD, Professor Dr. med., University of Schleswig-Holstein
ClinicalTrials.gov Identifier: NCT03047174     History of Changes
Other Study ID Numbers: RAREST-01
First Posted: February 8, 2017    Key Record Dates
Last Update Posted: July 11, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Prof. Dirk Rades, MD, University of Schleswig-Holstein:
Head and Neck Neoplasms, Radio(chemo)therapy

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Mometasone Furoate
Anti-Inflammatory Agents
Dermatologic Agents
Anti-Allergic Agents