Evidence map›Paper›PMID 41338634›Full record

ArticleBMJ open2025

Transtympanic sodium thiosulphate to prevent cisplatin-related hearing loss: a protocol for randomised controlled multicentre phase III trial, the SOUND trial.

Anouk V M Burger, Charlotte W Duinkerken, Jeroen C Jansen, Stijn Keereweer, Froukje L Cals, Robert J Stokroos, Jan Paul de Boer, Leonie Exterkate, Lilly-Ann van der Velden, Alexander E Hoetink and 5 more

Abstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–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.

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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

15 authors.

Anouk V M BurgerDepartment of Head and Neck Surgery and Oncology, The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, Amsterdam, Netherlands.ORCID http://orcid.org/0000-0003-0435-3981
Charlotte W DuinkerkenDepartment of Otorhinolaryngology - Head and Neck surgery, Leiden University Medical Center, Leiden, Netherlands.
Jeroen C JansenDepartment of Otorhinolaryngology - Head and Neck surgery, Leiden University Medical Center, Leiden, Netherlands.
Stijn KeereweerDepartment of Otolaryngology and Head and Neck Surgery, Erasmus MC University Medical Center Rotterdam, Rotterdam, Netherlands.
Froukje L CalsDepartment of Otorhinolaryngology, Radboud University Medical Center, Nijmegen, GE, Netherlands.
Robert J StokroosDepartment of Otorhinolaryngology-Head and Neck Surgery, University Medical Centre Utrecht, Utrecht, Netherlands.
Jan Paul de BoerDepartment of Medical Oncology, The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, Amsterdam, Netherlands.
Leonie ExterkateDepartment of Radiation Oncology, The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, Amsterdam, Netherlands.
Lilly-Ann van der VeldenDepartment of Head and Neck Surgery and Oncology, The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, Amsterdam, Netherlands.
Alexander E HoetinkDepartment of Otorhinolaryngology-Head and Neck Surgery, University Medical Centre Utrecht, Utrecht, Netherlands.
Bastiaan NuijenDepartment of Pharmacy & Pharmacology, The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, Amsterdam, Netherlands.
Michael HauptmannBiometrie und Registerforschung, Brandenburg Medical School Theodor Fontane, Neuruppin, Brandenburg, Germany.
Klaske E van SluisDepartment of Head and Neck Surgery and Oncology, The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, Amsterdam, Netherlands.
Tjasse D BruintjesDepartment of Otorhinolaryngology - Head and Neck surgery, Leiden University Medical Center, Leiden, Netherlands.ORCID http://orcid.org/0000-0001-5955-8453
Charlotte L ZuurDepartment of Head and Neck Surgery and Oncology, The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, Amsterdam, Netherlands c.zuur@nki.nl.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionCisplatin is a widely used chemotherapeutic anti-cancer drug. However, high-dose cisplatin is also known for its dose-limiting toxicities, including irreversible cisplatin-induced hearing loss (CIHL). Sodium thiosulphate (STS) can bind to cisplatin to form an inactive and harmless complex. A topical application is desired, allowing cisplatin to retain its systemic anti-cancer effect. METHODS AND ANALYSIS: The SOUND trial is an investigator-initiated randomised controlled multicentre phase III trial to study the efficacy of transtympanic administration of STS against CIHL in a cohort of 100 patients with head and neck cancer treated with cisplatin at a dose of ≥200 mg/m ETHICS AND DISSEMINATION: The medical ethics committee in the Netherlands approved the trial (Clinical Trials Information System (CTIS) 2023-503313-30-00). The results will be disseminated through the CTIS and peer-reviewed scientific journals. TRIAL REGISTRATION NUMBER: CTIS 2023-503313-30-00 approved by Medical Research Ethics Committee NedMec.

Indexed as

Antineoplastic AgentsCisplatinHead and Neck NeoplasmsHearing LossThiosulfatesAdultClinical Trials, Phase III as TopicFemaleHumansInjection, IntratympanicMaleMulticenter Studies as TopicRandomized Controlled Trials as TopicAntineoplastic AgentsCisplatinsodium thiosulfateThiosulfatesCHEMOTHERAPYHearingONCOLOGYOtotoxicityPREVENTIVE MEDICINE

Identifiers

PMID41338634
PMCPMC12682161

What Socratic holds

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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 Socratic graph.