ClinicalTrials.gg
Active, not recruitingNCT05936034PROTOTOXUpdated Oct 22, 2026

Comparative Study of the Quality of Life of Patients Suffering From OTOTOXICITY Due to Chemotherapy Based on Platinum Salts Fitted With a Hearing Aid Compared to Those Not Fitted.

An interventional study of Patients suffering from chemotherapy-induced ototoxicity and Patients suffring from chemotherapy-induced ototoxicity wearing hearing aids in Cancer, Ototoxicity, Drug-Induced and Quality of Life, sponsored by Institut de Cancérologie de Lorraine. Active, not recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-22.

Sponsored by Institut de Cancérologie de Lorraine · Not applicable, Interventional, and Supportive care

Updated Oct 22, 2026Now Active, not recruitingPrimary completion moved+1 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
52
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

There are many undesirable effects associated with platinum-based cancer treatments (renal failure, anaemia, etc.). Their administration also leads to neurosensory problems such as ototoxicity, tinnitus and reduced hearing acuity. According to a the French survey (2018), 39.7% of people suffer from hearing problems due to cancer treatments, five years after a cancer diagnosis.

Improving side effects such as hypoacusis and tinnitus can significantly improve patients' quality of life and adherence to treatment. Many clinical trials proposed a medicinal solution to patients receiving platinum-based cancer treatments but none has led to a consensus on management.

The aim of the study is to offer patients receiving platinum-based chemotherapy and suffering from hearing problems a hearing aid to improve their quality of life.

02

Conditions studied

  • Cancer
  • Ototoxicity, Drug-Induced
  • Quality of Life
  • Hearing Disorders
03

In context

Neoplasms

10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.

This study's planned enrollment of 52 is below the median of 60 across 7,703 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Institut de Cancérologie de Lorraine is the lead sponsor of 62 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adult patient
  • Patient currently undergoing treatment with platinum-based chemotherapy and suffering from hypoacusia consistent with the treatment or presenting a worsening of already existing hypoacusis consistent with the start of treatment with platinum-based chemotherapy
  • Patient whose hypoacusis is confirmed by the audiometric test
  • Patient able and willing to follow all study procedures in accordance with the protocol.
  • Patient having understood, signed and dated the consent form
  • Patient affiliated to the social security system

Exclusion criteria

Exclusion Criteria:

  • Pregnant or breastfeeding woman
  • Persons deprived of liberty or under guardianship (including curatorship)
  • Impossibility of submitting to medical monitoring of the trial for geographical, social or psychological reasons
  • Patient with a to wearing hearing aids
  • Patient already fitted
  • Patient already included in a protocol including an experimental molecule
  • Patient who has not started treatment with platinum-based chemotherapy
  • Patient presenting only tinnitus without hearing loss
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
52 participants (estimated)

Study arms

  • Active comparator
    Patients suffering from chemotherapy-induced ototoxicity

    Arm 1: Patients with chemotherapy-induced ototoxicity who continue their usual care.

    Other: Patients suffering from chemotherapy-induced ototoxicity

  • Experimental
    Patients suffring from chemotherapy-induced ototoxicity wearing hearing aids

    Arm 2: Experimental group patients with chemotherapy-induced ototoxicity wearing a hearing aid to evaluate quality of life.

    Other: Patients suffring from chemotherapy-induced ototoxicity wearing hearing aids

Interventions

  • OtherPatients suffering from chemotherapy-induced ototoxicity

    At baseline, * medical staff carries out a clinical and audiometric and/or tintometric examination * patient completes the SF36 survey (36 Item Short-Form Health Survey) * Patients will then be randomized to either: * Control group: standard support; Once the patient has been fit, he continues his carcinological treatment with platinum-based chemotherapy according to the recommendations specific to his pathology. At one, three and six months after fitting, * medical staff carries out a clinical examination * This visit will be scheduled when the patient arrives as part of their standard care. all patients included in the study will have a clinical examination and an audiometric and/or tinnitus examination and should complete an SF36 quality of life questionnaire. Only at the last visit (6 months) all patients included should complete a satisfaction questionnaire.

  • OtherPatients suffring from chemotherapy-induced ototoxicity wearing hearing aids

    At baseline, * medical staff carries out a clinical and audiometric and/or tintometric examination * patient completes the SF36 survey (36 Item Short-Form Health Survey) * Patients will then be randomized to either: * Experimental group: standard treatment with hearing aids (wearing a hearing aid). Once the patient has been fit, he continues his carcinological treatment with platinum-based chemotherapy according to the recommendations specific to his pathology. At one, three and six months after fitting, * medical staff carries out a clinical examination * This visit will be scheduled when the patient arrives as part of their standard care. all patients included in the study will have a clinical examination and an audiometric and/or tinnitus examination and should complete an SF36 quality of life questionnaire. Only at the last visit (6 months) all patients included should complete a satisfaction questionnaire.

06

What researchers measure

Primary outcomes

  1. Quality of life of patients

    The quality of life of patients with hearing aids suffering from ototoxicity due to platinum-based chemotherapy will be assessed using the 36 Item Short-Form Health Survey (SF36). \[score 0 to 100 : score 0 representing the lowest possible scores and score 100 representing the highest possible scores. A higher score means better health.

    Time frame: 6 months

Secondary outcomes

  1. Measuring hearing and the onset of tinnitus in patients

    Hearing and the onset of tinnitus in hearing-aided patients suffering from chemotherapy-induced ototoxicity will be assessed by Hertz/Decibel measurement using an audiometer

    Time frame: 6 months

  2. Patient compliance to wearing a hearing aid

    Hearing aid compliance will be assessed according to the proportion of patients completing 6-month follow-up with a hearing aid among all included patients.

    Time frame: 6 months

07

Study locations

1 site
08

References and documents

Publications

  • Mastronicola R, Kayser E, Fernandez Y, Dolivet G. Comparative Study of the Quality of Life of Patients With Ototoxicity Due to Platinum-Based Chemotherapy, With Hearing Aid Versus Those Without: Study Protocol for a Randomized Pilot Study-The PROTOTOX Study. JMIR Res Protoc. 2025 Oct 10;14:e71562. doi: 10.2196/71562. PubMed 41071987 ↗

Individual participant data

Plan to share: No

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2024 (actual). Primary completion is estimated for Jun 2027, 41 months after the start.

Of 1,981 non-industry interventional studies with no phase under Neoplasms, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 52. This study's planned 41 months is above that.

Counting every sponsor, half of 2,056 studies reached it within 29 months; a quarter within 13 and three quarters within 52.

Neoplasms covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.

Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 22, 2026: primary completion Sep 2027 → Jun 2027 and completion Jul 2028 → Dec 2028.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Jun 21, 2023
First posted
Jul 7, 2023
StartActual
Jan 4, 2024
Primary completionEst.
Jun 5, 2027was Sep 2027
CompletionEst.
Dec 5, 2028was Jul 2028
Last update
Oct 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Recruiting→Active, not recruiting
changed Oct 22, 2026
Primary completion
Sep 4, 2027→Jun 5, 2027
Oct 22, 2026
Study completion
Jul 4, 2028→Dec 5, 2028
Oct 22, 2026
Show all 1 update
  1. Oct 22, 2026
    Recruiting→Active, not recruiting
    Primary completion Sep 4, 2027→Jun 5, 2027
    Study completion Jul 4, 2028→Dec 5, 2028
    + 2 other changes: contact details and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT05936034
Lead sponsor
Institut de Cancérologie de Lorraine
Responsible party
Sponsor
First posted
Jul 7, 2023
Start date
Jan 4, 2024
Primary completion
Jun 5, 2027 (estimated)
Completion
Dec 5, 2028 (estimated)
Last update
Oct 22, 2026

Study contacts

ROMINA MASTRONICOLA, MD
principal investigator · Institut de Cancérologie de Lorraine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion