Evidence map›Paper›PMID 37819539›Full record

Trial reportSupportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer2023

A novel, multi-active emollient for the prevention of acute radiation dermatitis in breast cancer patients: a randomized clinical trial.

Jolien Robijns, Leen Van Bever, Sanne Hermans, Marithé Claes, Joy Lodewijckx, Melissa Lenaerts, Laura Tuts, Eline Vandaele, Evelien Vinken, Leen Noé and 7 more

Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04929808 (Evaluation of a Novel Skin Care Product for the Management of Acute Radiodermatitis in Breast Cancer Patients), which is not on this map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
0.7field-weighted citation impact, top 27% 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.

NCT04929808 nacompletednot on this map

Evaluation of a Novel Skin Care Product for the Management of Acute Radiodermatitis in Breast Cancer Patients

TypeinterventionalSponsorJessa HospitalRan2022 to 2023Enrolled100ConditionsRadiodermatitis, Acute, Radiation DermatitisArmsHydrating emollient for acute radiodermatitis, Standard institutional skin care
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 3 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Article
  4. 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

17 authors at 3 institutions in 2 countries.

Jolien RobijnsFaculty of Medicine and Life Sciences, LCRC, Hasselt University, Agoralaan, 3590, Diepenbeek, Belgium. Jolien.Robijns@uhasselt.be.ORCID http://orcid.org/0000-0002-6286-1581
Leen Van BeverDept. Radiotherapy - Limburg Oncology Center, Jessa Hospital - Campus Virga Jessa, Stadsomvaart 11, 3500, Hasselt, Belgium.ORCID http://orcid.org/0000-0002-6776-4318
Sanne HermansDept. Radiotherapy - Limburg Oncology Center, Jessa Hospital - Campus Virga Jessa, Stadsomvaart 11, 3500, Hasselt, Belgium.
Marithé ClaesFaculty of Medicine and Life Sciences, LCRC, Hasselt University, Agoralaan, 3590, Diepenbeek, Belgium.ORCID http://orcid.org/0000-0002-0195-1655
Joy LodewijckxFaculty of Medicine and Life Sciences, LCRC, Hasselt University, Agoralaan, 3590, Diepenbeek, Belgium.ORCID http://orcid.org/0000-0003-4982-5196
Melissa LenaertsDepartment of Surgery GROW School for Oncology & Reproduction, Maastricht University, Universiteitssingel 50, 6229ER, Maastricht, The Netherlands.ORCID http://orcid.org/0000-0001-9687-4375
Laura TutsFaculty of Medicine and Life Sciences, LCRC, Hasselt University, Agoralaan, 3590, Diepenbeek, Belgium.
Eline VandaeleFaculty of Medicine and Life Sciences, LCRC, Hasselt University, Agoralaan, 3590, Diepenbeek, Belgium.
Evelien VinkenDept. Radiotherapy - Limburg Oncology Center, Jessa Hospital - Campus Virga Jessa, Stadsomvaart 11, 3500, Hasselt, Belgium.
Leen NoéDept. Radiotherapy - Limburg Oncology Center, Jessa Hospital - Campus Virga Jessa, Stadsomvaart 11, 3500, Hasselt, Belgium.
Katleen VerbovenDept. Radiotherapy - Limburg Oncology Center, Jessa Hospital - Campus Virga Jessa, Stadsomvaart 11, 3500, Hasselt, Belgium.
Annelies MaesDept. Radiotherapy - Limburg Oncology Center, Jessa Hospital - Campus Virga Jessa, Stadsomvaart 11, 3500, Hasselt, Belgium.
Anne-Sophie Van de VeldeDept. Radiotherapy - Limburg Oncology Center, Jessa Hospital - Campus Virga Jessa, Stadsomvaart 11, 3500, Hasselt, Belgium.ORCID http://orcid.org/0000-0001-5912-0013
Paul BulensDept. Radiotherapy - Limburg Oncology Center, Jessa Hospital - Campus Virga Jessa, Stadsomvaart 11, 3500, Hasselt, Belgium.
Philippe BulensDept. Radiotherapy - Limburg Oncology Center, Jessa Hospital - Campus Virga Jessa, Stadsomvaart 11, 3500, Hasselt, Belgium.ORCID http://orcid.org/0000-0001-7450-4162
Laura Van den BerghDept. Radiotherapy - Limburg Oncology Center, Jessa Hospital - Campus Virga Jessa, Stadsomvaart 11, 3500, Hasselt, Belgium.ORCID http://orcid.org/0000-0001-6598-1493
Jeroen MebisFaculty of Medicine and Life Sciences, LCRC, Hasselt University, Agoralaan, 3590, Diepenbeek, Belgium.ORCID http://orcid.org/0000-0003-0579-4607
Jessa Hospital · BEHasselt University · BEMaastricht University · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo investigate the efficacy of a novel, multi-active emollient in preventing and managing acute radiation dermatitis (ARD) in breast cancer patients undergoing moderate hypofractionated (HF) radiotherapy (RT) compared to standard of care. METHODSA: A monocentric, open-label, randomized clinical trial (RCT) with breast cancer patients receiving moderate HF (dose: 40.05-55.86 Gy, fractions: 15-21) was conducted between January 2022 and May 2023. The experimental group received the novel emollient, while the control group received the standard skin care. Patients applied the skin care products twice daily during the complete RT course. The primary outcome was the severity of ARD at the final RT session measured by the modified Radiation Therapy Oncology Group (RTOG) criteria. Secondary outcomes included patient symptoms, quality of life (QoL), and treatment satisfaction.

resultsA total of 100 patients with 50 patients per group were enrolled. In the control group, 50% of the patients developed RTOG grade 1 ARD and 48% grade 2 or higher, while in the experimental group, the severity of ARD was significantly lower with 82% grade 1 and 16% grade 2 ARD (P = .013, χ

conclusionThis RCT shows that the novel, multi-active emollient significantly reduced the ARD RTOG grade. Research in a more diverse patient population is warranted.

trial registrationClinicalTrials.gov: NCT04929808 (11/06/2021).

Indexed as

Breast NeoplasmsRadiodermatitisEmollientsFemaleHumansSkin CareEmollientsAcute radiation dermatitisEmollientsRadiodermatitisRadiotherapySkin careSkin toxicity

Identifiers

PMID37819539
OpenAlexW4387537994

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.