Evidence map›Paper›PMID 37851095›Full record

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

Sodium-hyaluronate mouthwash on radiotherapy-induced xerostomia: a randomised clinical trial.

Cosimo Rupe, Alessia Basco, Gioele Gioco, Romeo Patini, Alberta Lucchese, Francesco Micciché, Mariangela Massaccesi, Carlo Lajolo

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Full text at PMC 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 NCT05103124 (Efficacy of GUM Hydral Mouthwashes on Symptoms of Radiotherapy-induced Xerostomia), 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
–field-weighted citation impact
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.

NCT05103124 nacompletednot on this map

Efficacy of GUM Hydral Mouthwashes on Symptoms of Radiotherapy-induced Xerostomia: a Randomized, Double-blind, Crossover Study.

TypeinterventionalSponsorCatholic University of the Sacred HeartRan2020 to 2022Enrolled40ConditionsXerostomia, Xerostomia Following RadiotherapyArmsHydral, Placebo
3 · Its place in the literature

Who cites it

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

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

8 authors.

Cosimo RupeHead and Neck Department, School of Dentistry, Fondazione Policlinico Universitario A. Gemelli-IRCCS, Università Cattolica del Sacro Cuore, Largo A. Gemelli, 8, 00168, Rome, Italy.
Alessia BascoHead and Neck Department, School of Dentistry, Fondazione Policlinico Universitario A. Gemelli-IRCCS, Università Cattolica del Sacro Cuore, Largo A. Gemelli, 8, 00168, Rome, Italy.
Gioele GiocoHead and Neck Department, School of Dentistry, Fondazione Policlinico Universitario A. Gemelli-IRCCS, Università Cattolica del Sacro Cuore, Largo A. Gemelli, 8, 00168, Rome, Italy. gioele.gioco@hotmail.it.
Romeo PatiniHead and Neck Department, School of Dentistry, Fondazione Policlinico Universitario A. Gemelli-IRCCS, Università Cattolica del Sacro Cuore, Largo A. Gemelli, 8, 00168, Rome, Italy.
Alberta LuccheseMultidisciplinary Department of Medical-Surgical and Dental Specialties, University of Campania "Luigi Vanvitelli", Via Luigi de Crecchio 6, 80138, Naples, Italy.
Francesco MiccichéDepartment of Radiation Oncology, Fondazione Policlinico Universitario A. Gemelli-IRCCS, Institute of Radiology, Università Cattolica del Sacro Cuore, Largo A. Gemelli, 8, 00168, Rome, Italy.
Mariangela MassaccesiDepartment of Radiation Oncology, Fondazione Policlinico Universitario A. Gemelli-IRCCS, Institute of Radiology, Università Cattolica del Sacro Cuore, Largo A. Gemelli, 8, 00168, Rome, Italy.
Carlo LajoloHead and Neck Department, School of Dentistry, Fondazione Policlinico Universitario A. Gemelli-IRCCS, Università Cattolica del Sacro Cuore, Largo A. Gemelli, 8, 00168, Rome, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionRadiotherapy-induced xerostomia (RIX) is one of the most common adverse effects of radiotherapy (RT) in head and neck cancer patients (HNC) and a major determinant of survivors' quality of life. The primary objective was to evaluate the reduction of patients' xerostomia symptoms after the utilisation of a sodium-hyaluronate mouthwash compared to a placebo solution. The secondary objectives were to evaluate the improvement of quality of life and to evaluate the patients' satisfaction.

methodsThe protocol was approved by the ethical committee (Ref. 50,053/19) and registered at ClinicalTrials.gov (ID: NCT05103124). The study was a double-blind randomised clinical trial (RCT) with a crossover design and was conducted at the Fondazione Policlinico Universitario A. Gemelli, Rome.

resultsThirty-two patients completed the study protocol. Lower values of the modified Xerostomia Questionnaire (XQ) were retrieved when comparing the baseline scores to the ones after the treatment, when compared with placebo (Mann-Whitney U test = 0.01); higher values of patients' satisfaction (Likert scale) and modified XQ were retrieved for the sodium-hyaluronate mouthwash (Mann-Whitney U test = 0.001).

conclusionsThis RCT highlights the advantages of treating RIX with the sodium-hyaluronate mouthwash since it seems to be clinically effective in reducing its symptoms, without any reported adverse events. CLINICALTRIALS: gov: NCT05103124 in 17/10/2021.

Indexed as

Head and Neck NeoplasmsRadiation OncologyXerostomiaHumansHyaluronic AcidMouthwashesQuality of LifeSodiumHyaluronic AcidMouthwashesSodiumGUM Hydral®MouthwashPlaceboRadiotherapyRadiotherapy-induced xerostomiaXerostomia

Identifiers

PMID37851095
PMCPMC10584731

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.