CancerPROTOTOXNCT05936034

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.

A study testing Patients suffering from chemotherapy-induced ototoxicity and Patients suffring from chemotherapy-induced ototoxicity wearing hearing aids in people with Cancer and Ototoxicity, Drug-Induced, run by Institut de Cancérologie de Lorraine at 1 site in France.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Cancer, Ototoxicity, Drug-Induced, Quality of Life
What is being tested?: Patients suffering from chemotherapy-induced ototoxicity and Patients suffring from chemotherapy-induced ototoxicity wearing hearing aids
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 52 participants
Where: 1 siteFrance
Study dates: 4 Jan 2024to 5 Dec 2028
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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 contraindication 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

Trial locations and contacts

1 site in 1 country.

France1 site

Institut de Cancerologie de Lorraine
Vandœuvre-lès-Nancy, 54500

Other trials in France

About this study

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.

Conditions: Cancer, Ototoxicity, Drug-Induced, Quality of Life, Hearing Disorders
Being tested: Patients suffering from chemotherapy-induced ototoxicity, Patients suffring from chemotherapy-induced ototoxicity wearing hearing aids
Medical subject headings: Neoplasms, Ototoxicity, Hearing Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Patients suffering from chemotherapy-induced ototoxicityOther
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.
Patients suffring from chemotherapy-induced ototoxicity wearing hearing aidsOther
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.

Study groups in NCT05936034
Study group	Role	What they receive
Patients suffering from chemotherapy-induced ototoxicity	Active comparator	Arm 1: Patients with chemotherapy-induced ototoxicity who continue their usual care. Receives: Other: Patients suffering from chemotherapy-induced ototoxicity
Patients suffring from chemotherapy-induced ototoxicity wearing hearing aids	Experimental	Arm 2: Experimental group patients with chemotherapy-induced ototoxicity wearing a hearing aid to evaluate quality of life. Receives: Other: Patients suffring from chemotherapy-induced ototoxicity wearing hearing aids

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 6 months

Secondary outcomes (2)

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
Measured: 6 months
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.
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Jan 20245 Dec 2028

First posted7 Jul 2023
Study start4 Jan 2024
Primary completion5 Jun 2027 (estimated)
Study completion5 Dec 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 52 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05936034
Sponsor's protocol ID: 2023-A02141-44
Acronym: PROTOTOX
Status last verified: Aug 2026
First submitted: 21 Jun 2023
Last updated: 22 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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