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