Clinical trial · Interventional
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Hearing Disorders | — | UNRESOLVED | — |
| Ototoxicity, Drug-Induced | — | UNRESOLVED | — |
| Quality of Life | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Patients suffering from chemotherapy-induced ototoxicity | Other | — | UNRESOLVED |
| Patients suffring from chemotherapy-induced ototoxicity wearing hearing aids | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Patients suffering from chemotherapy-induced ototoxicity
- description
- Arm 1: Patients with chemotherapy-induced ototoxicity who continue their usual care.
- interventionNames
- Other: Patients suffering from chemotherapy-induced ototoxicity
- type
- EXPERIMENTAL
- label
- Patients suffring from chemotherapy-induced ototoxicity wearing hearing aids
- description
- Arm 2: Experimental group patients with chemotherapy-induced ototoxicity wearing a hearing aid to evaluate quality of life.
- interventionNames
- Other: Patients suffring from chemotherapy-induced ototoxicity wearing hearing aids
Primary outcomes (1)
- measure
- Quality of life of patients
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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: * 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
References
Publications (1)
- BACKGROUNDMastronicola 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. PMID 41071987