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.
Trial 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. Read more about this study
- 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
- Are there results?
- Not yet: the study is under way
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.
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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Institut de Cancérologie de Lorraine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ROMINA MASTRONICOLA, MD, Principal investigator, Institut de Cancérologie de Lorraine
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT05936034
- Acronym / sponsor ID
- PROTOTOX / 2023-A02141-44
- Conditions
- Cancer, Ototoxicity, Drug-Induced, Quality of Life, Hearing Disorders
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Institut de Cancérologie de LorraineUniversity, hospital or other
- Study start
- 4 Jan 2024 (actual)
- Primary completion
- 5 Jun 2027 (estimated)
- Study completion
- 5 Dec 2028 (estimated)
- First posted
- 7 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients suffering from chemotherapy-induced ototoxicity | Active comparator | Other: Patients suffering from chemotherapy-induced ototoxicityArm 1: Patients with chemotherapy-induced ototoxicity who continue their usual care. |
| Patients suffring from chemotherapy-induced ototoxicity wearing hearing aids | Experimental | Other: Patients suffring from chemotherapy-induced ototoxicity wearing hearing aidsArm 2: Experimental group patients with chemotherapy-induced ototoxicity wearing a hearing aid to evaluate quality of life. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patients suffering from chemotherapy-induced ototoxicityAt 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. | Other | Patients suffering from chemotherapy-induced ototoxicity |
| Patients suffring from chemotherapy-induced ototoxicity wearing hearing aidsAt 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. | Other | Patients suffring from chemotherapy-induced ototoxicity wearing hearing aids |
Primary outcome
Quality of life of patients
Time frame: 6 months
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.
2 secondary outcomes
Measuring hearing and the onset of tinnitus in patients
Time frame: 6 months
Patient compliance to wearing a hearing aid
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Background: PubMed 41071987Mastronicola 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.
- Individual participant dataSharing planned: No
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ROMINA MASTRONICOLA, MD principal investigator
Institut de Cancérologie de Lorraine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life of patients (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05936034, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.