Evidence map›Paper›PMID 21603988›Full record

Trial reportStrahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al]2011

Treatment of acute radiodermatitis with an oil-in-water emulsion following radiation therapy for breast cancer: a controlled, randomized trial.

Jens-Michael Jensen, Tanja Gau, Jürgen Schultze, Gunter Lemmnitz, Regina Fölster-Holst, Theodor May, Christoph Abels, Ehrhardt Proksch

Abstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al], 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 3 pooled it
2.4field-weighted citation impact, top 13% of its field
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 3 syntheses or guidelines pooled it, 34 citations in OpenAlex.

  1. Pooled it
  2. Guideline
  3. Pooled it
  4. Biophysical skin measurements to evaluate the effectiveness of photobiomodulation therapy in the prevention of acute radiation dermatitis in breast cancer patients.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2019
    Trial
  5. Trial
  6. Trial
  7. Review
  8. Article
  9. Article
  10. Article
  11. Adenosine A2A receptor plays an important role in radiation-induced dermal injury.FASEB journal : official publication of the Federation of American Societies for Experimental Biology · 2016
    Article
  12. Clinical practice guidelines for the prevention and treatment of acute and late radiation reactions from the MASCC Skin Toxicity Study Group.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2013
    Review
  13. Article
  14. Ionizing radiation: the good, the bad, and the ugly.The Journal of investigative dermatology · 2012
    Review
  15. [New insights into the pathogenesis of sensitive skin].Der Hautarzt; Zeitschrift fur Dermatologie, Venerologie, und verwandte Gebiete · 2011
    Article
  16. Skin barrier function in patients under radiation therapy due to the head and neck cancers - Preliminary study.Reports of practical oncology and radiotherapy : journal of Greatpoland Cancer Center in Poznan and Polish Society of Radiation Oncology
    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 at 4 institutions in 1 country.

Jens-Michael JensenDepartment of Dermatology, University Hospitals of Schleswig-Holstein, University of Kiel, Germany. mjensen@dermatology.uni-kiel.de
Tanja Gau
Jürgen Schultze
Gunter Lemmnitz
Regina Fölster-Holst
Theodor May
Christoph Abels
Ehrhardt Proksch
University Hospital Schleswig-Holstein · DEDr. August Wolff (Germany) · DEUniversity of Lübeck · DEZimmer Biomet (Germany) · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundA side effect of radiotherapy for breast cancer is acute radiodermatitis. It is a common practice to keep irradiated skin dry on account of data from the 1950s that suggested this regimen limits dermatitis. However, severe dryness of the skin induced by irradiation results in itching and discomfort. Dry skin is characterized by scaliness, epidermal barrier dysfunction, and reduced stratum corneum hydration, and these signs and symptoms are reduced by treatment with an emulsion. PATIENTS AND

methodsWe performed a randomized, controlled, open-label study with 66 patients (ITT population), treating the irradiated skin in one group (n = 34) with an oil-in-water emulsion (WO1932), while leaving the other group untreated (n = 32). Clinical scoring (ONS radiation skin reaction scoring, pruritus) and biophysical measurements (stratum corneum hydration and transepidermal water loss (TEWL), as a marker of skin barrier function) were determined at day 1 (directly after termination of the radiation therapy), day 8, and day 47 (± 7).

resultsIrradiation increased the ONS score and pruritus, whereas skin hydration and TEWL were reduced. The primary hypothesis that the increase in skin hydration was significantly greater in the emulsion-treated compared to the untreated group as early as after 8 days of treatment could not be confirmed. At the end of the study (day 47 ± 7), however, normalization of stratum corneum hydration was more advanced in the treatment group compared to the untreated group and nearly reached the values of the contralateral healthy breast skin. ONS score and pruritus also revealed an advantage for the emulsion-treated group. TEWL did not show significant changes during emulsion treatment. No adverse events were caused by the treatment regimens

conclusionTreatment of radiodermatitis with an oil-in-water emulsion was well tolerated, enhanced stratum corneum hydration, improved clinical indicators, and provided relief from itching.

Indexed as

AdultBreast NeoplasmsDermatologic AgentsEmulsionsEpidermisFemaleHumansRadiodermatitisRadiotherapyTime FactorsTreatment OutcomeDermatologic AgentsEmulsions

Identifiers

PMID21603988
OpenAlexW1586845910

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.