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Ear gel may shield cancer patients from Chemo-Induced deafness

NCT ID NCT07281508

Prevention Sponsor: The Netherlands Cancer Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether injecting a special gel (sodium thiosulfate) into the ear before each round of cisplatin chemotherapy can prevent hearing loss. About 100 adults with head and neck cancer will receive the gel in one ear only, so the treated ear can be compared to the untreated ear. The goal is to see if the gel protects hearing without affecting the cancer treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

Mar 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Histological or cytological proof of solid head and neck malignancies with an indication for treatment with cisplatin in a cumulative dose of ≥ 200mg/m2 given in a weekly schedule of 7 times 40 mg/m2 or a 3-weekly schedule of 3 times 100 mg/m2 * Treatment with high-dose cisplatin (cumulative dose ≥ 200mg/m2) of maximum 7 cycles * Able and willing to give written informed consent; * WHO performance status of 0, 1 or 2; * Age older than 18 years. Exclusion Criteria: * Asymmetric hearing capacity (SNHL) prior to treatment, defined as a difference between both ears in hearing capacity of ≥ 10 dB averaged over 3 adjacent frequencies in the range of 0.5 to 12.5 kHz (i.e. 0.5, 1, 2, 4, 8, 10 and 12.5 kHz). * Baseline hearing: more than 40 dB SNHL at PTA 1-2-4 kHz (in one or both ears) * A planned radiation dose of \> 30 Gy to the cochlea (8); * Known hypersensitivity to STS-containing HYA gel formulation; * Any condition that would, according to the investigator's judgement, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures; * Otologic pathology that hampers the transtympanically applied STS gel to diffuse through the round window, e.g. otosclerosis, a narrow ear canal, otitis media with effusion.

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Conditions

The condition(s) this trial relates to.

head and neck cancer platinum-induced ototoxicity prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cisplatin-related hearing loss

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    5 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Antoni van Leeuwenhoek

    RECRUITING

    Amsterdam, North Holland, 1066CX, Netherlands

  • Erasmus Universitair Medisch Centrum Rotterdam

    NOT_YET_RECRUITING

    Rotterdam, South Holland, 3015GD, Netherlands

  • Leiden University Medical Center

    RECRUITING

    Leiden, South Holland, 2333ZA, Netherlands

  • Stichting Radboud University Medical Center

    NOT_YET_RECRUITING

    Nijmegen, 6525GA, Netherlands

  • University Medical Center Utrecht

    NOT_YET_RECRUITING

    Utrecht, Utrecht, 3584CX, Netherlands

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