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.

Обзор

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.

Вмешательства

• Другое Patients suffering from chemotherapy-induced ototoxicity
  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 cli
• Другое Patients suffring from chemotherapy-induced ototoxicity wearing hearing aids
  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

Первичные конечные точки

• Quality of life of patients [Срок оценки: 6 months]

Вторичные конечные точки (2)

• Measuring hearing and the onset of tinnitus in patients [Срок оценки: 6 months]
• Patient compliance to wearing a hearing aid [Срок оценки: 6 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Франция · 1 центр

• Institut de Cancerologie de Lorraine — Vandœuvre-lès-Nancy

Идентификаторы

NCT: NCT05936034 · 2023-A02141-44

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗