Evidence map›Paper›PMID 36385713›Full record

Trial reportJournal of pineal research2023

Quality-of-life outcomes following topical melatonin application against acute radiation dermatitis in patients with early breast cancer: A double-blind, randomized, placebo-controlled trial.

Dennis Zetner, Claus Kamby, Sengül Gülen, Camilla Christophersen, Cecilie B Paulsen, Emily Piga, Bodil Hoffmeyer, Faisal Mahmood, Jacob Rosenberg

Open access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of pineal research, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 2 pooled it
1.7field-weighted citation impact, top 16% 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

14 citing papers in PubMed, 2 syntheses or guidelines pooled it, 13 citations in OpenAlex.

  1. Melatonin in cancer treatment.The Cochrane database of systematic reviews · 2025
    Pooled it
  2. Pooled it
  3. Trial
  4. Review
  5. Review
  6. Review
  7. Article
  8. Review
  9. Article
  10. Melatonin's Impact on Wound Healing.Antioxidants (Basel, Switzerland) · 2024
    Review
  11. Clinical Studies Using Topical Melatonin.International journal of molecular sciences · 2024
    Review
  12. Review
  13. Review
  14. 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

9 authors at 2 institutions in 1 country.

Dennis ZetnerDepartment of Surgery, Herlev Hospital, University of Copenhagen, Herlev, Denmark.ORCID http://orcid.org/0000-0002-8533-8777
Claus KambyDepartment of Oncology, Rigshospitalet, University of Copenhagen, Copenhagen Ø, Denmark.
Sengül GülenDepartment of Surgery, Herlev Hospital, University of Copenhagen, Herlev, Denmark.
Camilla ChristophersenDepartment of Surgery, Herlev Hospital, University of Copenhagen, Herlev, Denmark.
Cecilie B PaulsenDepartment of Surgery, Herlev Hospital, University of Copenhagen, Herlev, Denmark.
Emily PigaDepartment of Surgery, Herlev Hospital, University of Copenhagen, Herlev, Denmark.
Bodil HoffmeyerDepartment of Surgery, Herlev Hospital, University of Copenhagen, Herlev, Denmark.
Faisal MahmoodDepartment of Oncology, Odense University Hospital, University of Southern Denmark, Odense, Denmark.
Jacob RosenbergDepartment of Surgery, Herlev Hospital, University of Copenhagen, Herlev, Denmark.
University of Copenhagen · DKUniversity of Southern Denmark · DK

Funding

RepoCeuticals A/S
6 · The paper itself

Abstract

The aim of this double-blind, placebo-controlled, randomized study was to investigate whether topical melatonin administered during radiation therapy could increase the quality of life in patients with primary breast cancer. Patients were followed from the first radiation fraction until 3 weeks after the last. The patients applied 1 g of cream to the irradiated area of the skin twice daily, consisting of either 25 mg/g melatonin and 150 mg/g dimethyl sulfoxide, or a placebo cream. Outcomes were the European Organisation for Research and Treatment of Cancer's quality-of-life questionnaires for breast cancer (QLQ-C30 and QLQ-BR23) on the last day of radiation therapy. As a secondary outcome, we evaluated the breast symptom (BS) scores over the entire duration of the trial in a repeated measures linear model. We included 65 patients and had 17 drop-outs, thus totaling 26 and 22 patients in the melatonin and placebo groups, respectively. BS scores on the last day of radiation did not differ between groups (p = .333). However, the linear model analyzing BS for the entire duration showed that melatonin significantly decreased the symptoms (p = .001). There was no difference in the BS score on the last day of radiation, however, we found that the patients in the melatonin group had significantly lower BS scores over the entire duration of the trial.

Indexed as

Breast NeoplasmsDermatitisMelatoninDouble-Blind MethodFemaleHumansQuality of LifeMelatoninbreast cancermelatoninQLQ-BR23QLQ-C30quality of liferadiation dermatitisrandomized clinical trial

Identifiers

PMID36385713
PMCPMC10078485
OpenAlexW4309247559

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.