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Active Not Recruiting NCT05936034

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.

Conditions: Cancer, Ototoxicity, Drug-Induced, Quality of Life, Hearing Disorders

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 52
Sponsor: Institut de Cancérologie de Lorraine

Location: Institut de Cancerologie de Lorraine Vandœuvre-lès-Nancy

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.

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

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05936034). StuddyBuddy aggregates publicly available trial information.