Evidence map›Paper›PMID 38055076›Full record

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

Head and neck cancer patients under radiotherapy undergoing skin application of hydrogel dressing or hyaluronic acid: results from a prospective, randomized study.

Marion Perréard, Natacha Heutte, Bénédicte Clarisse, Maxime Humbert, Alexandra Leconte, Bernard Géry, Thomas Boisserie, Nathalie Dadoun, Laurent Martin, David Blanchard and 2 more

Abstract readRandomized Controlled TrialMulticenter Study
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. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
2.0field-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

3 citing papers in PubMed, 6 citations in OpenAlex.

  1. Review
  2. Review
  3. 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

12 authors at 5 institutions in 1 country.

Marion PerréardDepartment of Otolaryngology-Head and Neck Surgery, CHU de Caen, Avenue de La Côte de Nacre, 14000, Caen, France. perreard.marion@gmail.com.
Natacha HeutteDepartment of Clinical Research, Center François Baclesse, Avenue du Général Harris, Caen, France.
Bénédicte ClarisseDepartment of Clinical Research, Center François Baclesse, Avenue du Général Harris, Caen, France.
Maxime HumbertDepartment of Otolaryngology-Head and Neck Surgery, CHU de Caen, Avenue de La Côte de Nacre, 14000, Caen, France.
Alexandra LeconteDepartment of Clinical Research, Center François Baclesse, Avenue du Général Harris, Caen, France.
Bernard GéryDepartment of Radiotherapy, Center François Baclesse, Avenue du Général Harris, Caen, France.
Thomas BoisserieCentre d'Oncologie Et de Radiothérapie CORT37, Chambray-Lès-Tours, France.
Nathalie DadounHôpital Privé de La Baie, Avranches, France.
Laurent MartinCentre Guillaume Le Conquérant, Le Havre, France.
David BlanchardHôpital Privé Saint Martin, Caen, France.
Emmanuel BabinDepartment of Otolaryngology-Head and Neck Surgery, CHU de Caen, Avenue de La Côte de Nacre, 14000, Caen, France.
Vianney BastitDepartment of Otolaryngology-Head and Neck Surgery, CHU de Caen, Avenue de La Côte de Nacre, 14000, Caen, France.
Centre François Baclesse · FRInserm · FRCentre Hospitalier Universitaire de Caen Normandie · FRGroupe d'Oncologie Radiothérapie Tête et Cou · FRHôpital Privé Jacques Cartier · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeAcute radiodermatitis (ARD) is a frequent side effect of radiotherapy, a therapeutic option for head and neck squamous cell carcinoma (HNSCC). It is responsible for pain, quality of life (QoL) impairment, and increased risk of treatment discontinuation, which may compromise the prognosis for patients. Local therapies to prevent or alleviate ARD have been proposed without providing any high level of evidence to establish recommendations.

methodsWe implemented a prospective multicenter randomized study on patients with HNSCC treated with definitive radiotherapy to assess the impact on ear, nose, and throat (ENT) pain of the application of a hydrogel-based skin dressing (HydroTac®) compared with the application of hyaluronic acid (Ialuset®) during radiotherapy.

resultsOut of 130 enrolled patients, 48 patients per group were assessable for the main endpoint. No difference between groups was found: a worsening of ENT pain of 3 points or more on a visual analog scale from the initiation to 1 month after the end of the radiotherapy was observed for 8 patients (16.7%) who received HydroTac® compared to 13 patients (27%) who received Ialuset® (p = 0.342). The proportion of patients who experienced ARD and grades of ARD (CTCAE v4.0 criteria) were similar between groups. Patient compliance with radiodermatitis treatment was poor, with 56.1% of patients in the HydroTac® group having their treatment temporarily stopped.

conclusionThe application of a hydrogel dressing to prevent ARD during radiotherapy for HNSCC patients has failed to demonstrate a benefit. These results may be limited by the difficulties of applying the dressing.

Indexed as

Head and Neck NeoplasmsRadiodermatitisBandagesHumansHyaluronic AcidHydrogelsPainProspective StudiesQuality of LifeSquamous Cell Carcinoma of Head and NeckHyaluronic AcidHydrogelsHead and neck squamous cell carcinoma (HNSCC)Hydrogel dressingRadiodermatitisRadiotherapySkin care

Identifiers

PMID38055076
OpenAlexW4389395330

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.