Evidence map›Paper›PMID 36115962›Full record

Trial reportBMC cancer2022

Impact of a mobile application (reminder app) on acute toxicity during radiotherapy of head-and-neck cancer - results of a randomized phase III trial (RAREST-02).

Dirk Rades, Inga Zwaan, Jon Cacicedo, Karl L Bruchhage, Samer G Hakim, Denise Olbrich, Steven E Schild, Soeren Tvilsted, Stefan Janssen

Open access · goldAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC cancer, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 2 pooled it
1.8field-weighted citation impact, top 14% 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

9 citing papers in PubMed, 2 syntheses or guidelines pooled it, 12 citations in OpenAlex.

  1. Pooled it
  2. Mobile applications in radiation oncology-current choices and future potentials.Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al] · 2023
    Pooled it
  3. Review
  4. Review
  5. Article
  6. Article
  7. Article
  8. Article
  9. The role of dermocosmetics in the management of cancer-related skin toxicities: international expert consensus.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2023
    Review
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 5 institutions in 4 countries.

Dirk RadesDepartment of Radiation Oncology, University of Lübeck, Ratzeburger Allee 160, 23562, Lübeck, Germany. dirk.rades@uksh.de.
Inga ZwaanDepartment of Radiation Oncology, University of Lübeck, Ratzeburger Allee 160, 23562, Lübeck, Germany.
Jon CacicedoDepartment of Radiation Oncology, Cruces University Hospital/ Biocruces Bizkaia Health Research Institute, Barakaldo, Vizcaya, Spain.
Karl L BruchhageDepartment of Oto-Rhino-Laryngology and Head and Neck Surgery, University of Lübeck, Lübeck, Germany.
Samer G HakimDepartment of Oral and Maxillofacial Surgery, University of Lübeck, Lübeck, Germany.
Denise OlbrichCentre for Clinical Trials Lübeck, Lübeck, Germany.
Steven E SchildDepartment of Radiation Oncology, Mayo Clinic Scottsdale, Scottsdale, AZ, USA.
Soeren TvilstedResearch Department, Zealand University Hospital, Køge, Denmark.
Stefan JanssenDepartment of Radiation Oncology, University of Lübeck, Ratzeburger Allee 160, 23562, Lübeck, Germany.
University of Lübeck · DEBioCruces Health research Institute · ESMayo Clinic in Arizona · USMedizinisches Laserzentrum Lübeck (Germany) · DEZealand University Hospital Køge · DK

Funding

European Regional Development Fund through the Interreg Deutschland-Danmark program 087-1.1-18
6 · The paper itself

Abstract

backgroundRadiotherapy of head-and-neck cancer (SCCHN) is often associated with acute toxicity. In a previous trial, daily reminders by staff members to perform skin care resulted in less dermatitis. This randomized trial investigated whether a mobile application can replace these reminders.

methodsPatients were stratified according to tumor site, treatment and center. Fifty-three patients were eligible for per-protocol-set (25 with, 28 without app). Primary endpoint was grade ≥ 2 dermatitis until 60 Gy. Secondary endpoints included dermatitis grade ≥ 2 until end of radiotherapy (EOT), dermatitis grade ≥ 3, and mucositis grade ≥ 2 and ≥ 3.

resultsAfter an interim analysis, the study was terminated (delayed and slow accrual). Until 60 Gy, grade ≥ 2 dermatitis rates were 72% with vs. 82% without app (p = 0.38), grade ≥ 3 dermatitis rates 20% vs. 11% (p = 0.45). Until EOT, grade ≥ 2 and ≥ 3 dermatitis rates were 72% vs. 86% (p = 0.22) and 24% vs. 18% (p = 0.58). Until 60 Gy, grade ≥ 2 and ≥ 3 mucositis rates were 76% vs. 82% (p = 0.58) and 20% vs. 36% (p = 0.20). Until EOT, corresponding mucositis rates were 76% vs. 82% (p = 0.58) and 28% vs. 43% (p = 0.26).

conclusionGiven the limitations of this trial, the reminder app led to non-significant reduction of grade ≥ 2 dermatitis, grade ≥ 2 mucositis and ≥ 3 mucositis. Additional studies are required to define the value of reminder apps during radiotherapy for SCCHN.

Indexed as

Head and Neck NeoplasmsMobile ApplicationsMucositisRadiation InjuriesRadiodermatitisHumansAcute toxicityHead-and-neck cancerMobile applicationRadio-chemotherapyRadiotherapy

Identifiers

PMID36115962
PMCPMC9482290
OpenAlexW4296151619

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.