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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.

Sponsor: Institut de Cancérologie de Lorraine • ClinicalTrials.gov ID: NCT05936034

Registry updated: 2026-09-01

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Description

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.

Interventions

Patients suffering from chemotherapy-induced ototoxicity (Other)
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 aids (Other)
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.

Eligibility criteria

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

Conditions

Cancer Ototoxicity, Drug-Induced Quality of Life Hearing Disorders

Locations

Institut de Cancerologie de Lorraine — Vandœuvre-lès-Nancy, France

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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