Evidence map›Paper›PMID 29454311›Full record

Trial reportBMC cancer2018

Radiotherapy related skin toxicity (RAREST-01): Mepitel® film versus standard care in patients with locally advanced head-and-neck cancer.

Carlos Narvaez, Claudia Doemer, Christian Idel, Cornelia Setter, Denise Olbrich, Zaza Ujmajuridze, Jesper Hansen Carl, Dirk Rades

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC cancer, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03047174 (Radiotherapy Related Skin Toxicity), which is not on this map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03047174 nacompletednot on this map

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

TypeinterventionalSponsorUniversity Hospital Schleswig-HolsteinRan2017 to 2019Enrolled57ConditionsHead and Neck NeoplasmsArmsMepitel® Film, Standard Care
3 · Its place in the literature

Who cites it

10 citing papers in PubMed.

  1. Trial
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  4. Radiomitigators: Breakthroughs in Post-Radiation Recovery.Antioxidants (Basel, Switzerland) · 2026
    Review
  5. Article
  6. Observational
  7. Article
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  9. Review
  10. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Carlos NarvaezDepartment of Radiation Oncology, University of Lübeck, Ratzeburger Allee 160, D-23562, Lübeck, Germany.
Claudia DoemerDepartment of Radiation Oncology, University of Lübeck, Ratzeburger Allee 160, D-23562, Lübeck, Germany.
Christian IdelDepartments of Radiation Oncology and Oto-Rhino-Laryngology and Head and Neck Surgery, University of Lübeck, Lübeck, Germany.
Cornelia SetterDepartment of Radiation Oncology, Christian-Albrechts University Kiel, Kiel, Germany.
Denise OlbrichCentre for Clinical Trials Lübeck, Lübeck, Germany.
Zaza UjmajuridzeDepartment of Oncology, Zealand University Hospital, Naestved, Denmark.
Jesper Hansen CarlDepartment of Oncology, Zealand University Hospital, Naestved, Denmark.
Dirk RadesDepartment of Radiation Oncology, University of Lübeck, Ratzeburger Allee 160, D-23562, Lübeck, Germany. Rades.Dirk@gmx.net.

Funding

European Union (Interreg) Innoc 11-1.0-15
6 · The paper itself

Abstract

backgroundThe aim of the present trial is to investigate a new option of skin protection in order to reduce the rate of grade ≥ 2 skin toxicity in patients receiving radiotherapy alone or radiochemotherapy for locally advanced squamous cell carcinoma of the head-and-neck (SCCHN). METHODS /

designThis is a randomized, active-controlled, parallel-group multi-center trial that compares the following treatments of radiation dermatitis in patients with head-and-neck cancer: Mepitel® Film (Arm A) vs. standard care (Arm B). The primary aim of this trial is to investigate the rate of patients experiencing grade ≥ 2 radiation dermatitis (according to Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.03) until 50 Gy of radiotherapy. Evaluation until 50 Gy of radiotherapy has been selected as the primary endpoint, since up to 50 Gy, the irradiated volume includes the primary tumor and the bilateral cervical and supraclavicular lymph nodes, and, therefore, is similar in all patients. After 50 Gy, irradiated volumes are very individual, depending on location and size of the primary tumor, involvement of lymph nodes, and the treatment approach (definitive vs. adjuvant). In addition, the following endpoints will be evaluated: Time to grade 2 radiation dermatitis until 50 Gy of radiotherapy, rate of patients experiencing grade ≥ 2 radiation dermatitis during radio(chemo)therapy, rate of patients experiencing grade ≥ 3 skin toxicity during radio(chemo)therapy, adverse events, quality of life, and dermatitis-related pain. Administration of Mepitel® Film will be considered to be clinically relevant, if the rate of grade ≥ 2 radiation dermatitis can be reduced from 85% to 65%. DISCUSSION: If administration of Mepitel® Film instead of standard care will be able to significantly reduce the rate of grade ≥ 2 radiation dermatitis, it could become the new standard of skin care in patients irradiated for SCCHN.

trial registrationclinicaltrials.gov NCT03047174 . Registered on 26th of January, 2017. First patient included on 9th of May, 2017.

Indexed as

ChemoradiotherapyFemaleHead and Neck NeoplasmsHumansMaleNeoplasm MetastasisNeoplasm StagingRadiodermatitisRadiotherapyRadiotherapy DosageSeverity of Illness IndexHead-and-neck cancerMepitel® filmRadiation dermatitisRadio(chemo)therapyStandard care

Identifiers

PMID29454311
PMCPMC5816351

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.