Clinical Research Directory

Prevention of Ototoxicity in NTM Patients Treated With IV Amikacin

The goal of this clinical trial is to test the effectiveness of the study drug, ORC-13361, in preventing hearing loss in patients with NTM infection who are undergoing treatment with IV amikacin therapy. The main question this study aims to answer is: * Is ORC-13661 effective for preventing or lessening hearing loss induced by amikacin treatment? * Is ORC-13661 effective for preventing or lessening other measures of hearing impairment? Participants will be asked to take a study drug while they are being treated with IV amikacin. Participants will take study drug for 90 days or until the end of their amikacin treatment, whichever comes first. During this time, researchers will gather clinical data on the participants' health. Researchers will compare three groups - two groups taking different doses of the study drug and one group taking a placebo drug - to see if dose of drug has any effect on preventing hearing loss. A placebo is a look-alike substance that contains no active drug.

Protective Effect of Acetylcysteine Against Cisplatinum-Induced Ototoxicity: A Randomized Controlled Trial

The purpose of this study is to evaluate the efficacy of N-acetylcysteine (NAC) in preventing cisplatin-induced ototoxicity in patients receiving cisplatin-based chemotherapy. Cisplatin is a highly effective chemotherapeutic agent but often leads to permanent hearing loss (ototoxicity) as a significant side effect. This study investigates whether the administration of NAC as an otoprotective agent can reduce or prevent the decline in hearing sensitivity, particularly at extended high frequencies, as measured by audiometry and distortion product otoacoustic emissions (DPOAE).

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.

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.

Analysis of Risk Factors for Hearing Loss in Survivors of Cancer Occurred During Childhood, Adolescence or Young Adulthood

This study is aimed at people treated for cancer before the age of 25, who have been followed for at least 5 years, and who are now aged between 18 and 50. It is a prospective, multicenter, non-randomized study. The main aim of the project is to identify hearing impaired patients using the iAudiogram medical device, and to analyze the risk factors associated with the risk of hearing impairment. Around 500 patients will take part in this study in France. Participation in this research project will consist in carrying out a hearing test (audiogram with tonal audiometry) with the iAudigram medical device (at Gustave Roussy, Curie or Necker Hospital) and completing self-questionnaires focusing on ototoxicity and its consequences.

Cisplatin-induced Cochlear and Vestibular Damage in Head and Neck Cancer

The goal of this observational study is to learn about the occurrence of and to identify suitable strategies for screening and monitoring of inner ear damage in patients receiving cisplatin chemoradiotherapy for head and neck cancer. Researchers will compare patients who are receiving cisplatin chemoradiotherapy to patients who are only receiving radiotherapy. Patients will undergo standardized testing for hearing loss, tinnitus and vestibular dysfunction at baseline, during and after treatment. Optional genetic analyses will aim to identify genes known to predispose to cisplatin-induced ototoxicity.

Diagnostic of Various Ototoxicity Induced by Cancer Treatment

• Visit the clinic once every 2 weeks for checkups and tests The goal of this clinical trial is to learn if systematic hearing tests (eg fonctional assesment, electrophysiology and seric biomarkers) can diagnose hidden hearing loss or vestibular troubles in a population of patients treated for cancer; population study will include different population in terms of sex/gender, age, medical condition (cancer patients treated with surgery alone and/or radiotherapy and/or chemotherapy, and healthy volunteers). The main question it aims to answer is: • To assess the ototoxicity of anticancer drugs using a combination of auditory functional tests (including speech audiometry in noise), vestibular test , plasmatic samples and electrophysiological measures. Participants will be studied: Either only after exposition (single visit) Or before, during and after the exposition to potential otototoxic agents with a 4 times Visit the clinic checkups and tests (one before, two while ongoing potential ototoxic agents and 1 post exposition) Participants will complete questionnaires, undergo audiometric and electrophysiological tests, and their routine biomedical data will be studied, without any modification of the routine care (planned cancer treatment)