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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 : Completed
First Posted : February 8, 2017
Results First Posted : March 9, 2020
Last Update Posted : March 24, 2020
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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 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
Actual Primary Completion Date : July 16, 2019
Actual Study Completion Date : July 16, 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. Number of Participants With Grade ≥2 Radiation Dermatitis at 50 Gy (Per Protocol Set) [ Time Frame: at 50 Gy (about 5 weeks) ]
    Radiation dermatitis has been assessed according to the Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.


Secondary Outcome Measures :
  1. Number of Participants With Grade ≥2 Radiation Dermatitis at 60 Gy (Per Protocol Set) [ Time Frame: at 60 Gy (about 6 weeks) ]
    Radiation dermatitis has been assessed according to the Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.

  2. Number of Participants With Grade ≥3 Radiation Dermatitis at 50 Gy (Per Protocol Set) [ Time Frame: at 50 Gy (about 5 weeks) ]
    Radiation dermatitis has been assessed according to the Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.

  3. Number of Participants With Grade ≥3 Radiation Dermatitis at 60 Gy (Per Protocol Set) [ Time Frame: at 60 Gy (about 6 weeks) ]
    Radiation dermatitis has been assessed according to the Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.

  4. Number of Participants With Grade ≥2 Radiation Dermatitis at 50 Gy (Intention-to-treat Population) [ Time Frame: at 50 Gy (about 5 weeks) ]
    Radiation dermatitis has been assessed according to the Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.

  5. Number of Participants With Grade ≥2 Radiation Dermatitis at 60 Gy (Intention-to-treat Population) [ Time Frame: at 60 Gy (about 6 weeks) ]
    Radiation dermatitis has been assessed according to the Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.

  6. Number of Participants With Grade ≥3 Radiation Dermatitis at 50 Gy (Intention-to-treat Population) [ Time Frame: at 50 Gy (about 5 weeks) ]
    Radiation dermatitis has been assessed according to the Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.

  7. Number of Participants With Grade ≥3 Radiation Dermatitis at 60 Gy (Intention-to-treat Population) [ Time Frame: at 60 Gy (about 6 weeks) ]
    Radiation dermatitis has been assessed according to the Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.

  8. Median Number of Radiation Fractions Until Occurence of Grade 2 Dermatitis [ Time Frame: up to 50 Gy (about 5 weeks) ]
    The number of fractions of radiotherapy up to 50 Gy (50 Gy = 25 fractions) was counted in the intent-to-treat population, until grade 2 radiation dermatitis occurred.

  9. Median Pain Score at the Irradiated Skin at 50 Gy [ Time Frame: at 50 Gy (about 5 weeks) ]
    The pain score will be assessed by using a numeric self rating scale from 0 (no pain) to 10 (maximum pain) points.

  10. Median Pain Score at the Irradiated Skin at 60 Gy [ Time Frame: at 60 Gy (about 6 weeks) ]
    The pain score will be assessed by using a numeric self rating scale from 0 (no pain) to 10 (maximum pain) points.

  11. Change in Quality of Life Between Screening and 50 Gy of Radiotherapy [ Time Frame: at 50 Gy (about 5 weeks) ]

    Quality of Life was assessed using the EORTC QLQ-C30 and QLQ-H&N35 questionnaires.

    For QLQ-C30, scoring of global health status and functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, social functioning) were assessed. Scores ranged from 0 to 100. A higher score represented a higher level of quality of life (global health status) and a higher level of functioning (functional scales).

    For QLQ-H&N35, symptom scales (pain, problems with swallowing, senses problems, speech problems, trouble with social eating, trouble with social contact) were assessed Scores ranged from 0 to 100. A higher score represented a higher level of symptomatology/problems.

    For both questionnaires (QLQ-C30 and QLQ-H&N35), the change between baseline and follow up at 50 Gy for each item was calculated by using the mean value of the differences between both time points of the evaluable patients.




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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


Locations
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Germany
Department of Radiotherapy (Radiooncology), Christian-Albrechts-Universität zu Kiel and University Medical Center Schleswig-Holstein Campus Kiel
Kiel, Schleswig-Holstein, Germany, 24105
Department of Radiation Oncology, University of Lübeck and University Medical Center Schleswig-Holstein
Lubeck, Germany, 23562
Sponsors and Collaborators
University of Schleswig-Holstein
Investigators
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Principal Investigator: Dirk Rades, Prof. Dr. Dep. of Radiation Oncology, Univ. of Lübeck, Univ. Med. Center S-H, Germany
  Study Documents (Full-Text)

Documents provided by Prof. Dirk Rades, MD, University of Schleswig-Holstein:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Prof. Dirk Rades, MD, Professor Dr. med., University of Schleswig-Holstein
ClinicalTrials.gov Identifier: NCT03047174    
Other Study ID Numbers: RAREST-01
First Posted: February 8, 2017    Key Record Dates
Results First Posted: March 9, 2020
Last Update Posted: March 24, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Head and Neck Neoplasms
Neoplasms
Neoplasms by Site