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.

Not Applicable

Recruiting

• Conditions: Ototoxicity, Drug-Induced; Cancer; Quality of Life; Hearing Disorders
• Interventions: Other: Patients suffering from chemotherapy-induced ototoxicity; Other: Patients suffring from chemotherapy-induced ototoxicity wearing hearing aids

• Registration Number: NCT05936034
• Lead Sponsor: Institut de Cancérologie de Lorraine

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-21
• Study First Submitted QC: 2023-06-29
• Study First Posted: 2023-07-07
• Status Verified: 2024-01
• Study Start: 2024-01-04
• Last Update Submitted: 2024-01-05
• Last Update Posted: 2024-01-09
• Primary Completion: 2025-07-04
• Study Completion: 2027-01-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients suffering from chemotherapy-induced ototoxicity	Patients suffering from chemotherapy-induced ototoxicity	Arm 1: Patients with chemotherapy-induced ototoxicity who continue their usual care.
Patients suffring from chemotherapy-induced ototoxicity wearing hearing aids	Patients suffring from chemotherapy-induced ototoxicity wearing hearing aids	Arm 2: Experimental group patients with chemotherapy-induced ototoxicity wearing a hearing aid to evaluate quality of life.

Primary Outcome Measures

Name	Time	Method
Quality of life of patients	6 months	The quality of life of patients with hearing aids suffering from ototoxicity due to platinum-based chemotherapy will be assessed using the 36 Item Short-Form Health Survey (SF36).; \[score 0 to 100 : score 0 representing the lowest possible scores and score 100 representing the highest possible scores. A higher score means better health.

Secondary Outcome Measures

Name	Time	Method
Patient compliance to wearing a hearing aid	6 months	Hearing aid compliance will be assessed according to the proportion of patients completing 6-month follow-up with a hearing aid among all included patients.
Measuring hearing and the onset of tinnitus in patients	6 months	Hearing and the onset of tinnitus in hearing-aided patients suffering from chemotherapy-induced ototoxicity will be assessed by Hertz/Decibel measurement using an audiometer

Trial Locations

Locations (1)

Institut de Cancérologie de Lorraine; 🇫🇷 Vandœuvre-lès-Nancy, France