Comparative Study of the Quality of Life of Patients With Ototoxicity Due to Platinum-Based Chemotherapy, With Hearing Aid Versus Those Without: Study Protocol for a Randomized Pilot Study-The PROTOTOX Study.

Abstract

Background: Platinum salts are widely used for the treatment of cancers, including head and neck cancers. Despite their efficacy, platinum salts can induce neurosensory disorders such as ototoxicity, tinnitus, and decreased hearing acuity. These side effects can have a major impact on the quality of life of patients and are not often considered after treatment.

Objective: The PROTOTOX study aims to compare the quality of life of patients with hearing aids in the case of ototoxicity due to platinum salt-based chemotherapy, according to 2 treatments: standard management without equipment versus standard management with equipment.

Methods: The PROTOTOX study is an open pilot prospective monocentric and randomized study executed through collaboration of the Institut de Cancérologie de Lorraine (nonprofit comprehensive cancer institute). A total of 52 patients with head and neck cancer undergoing platinum-based chemotherapy and presenting with hypoacusis will be included and followed by an ear, nose, and throat specialist. Audiometric testing will be performed, and eligible participants who consent will be randomized to either receive or not receive hearing aids (groups 1 and 2). The primary endpoint of this study is to compare the quality of life of the patients undergoing platinum-based chemotherapy presenting with hypoacusis according to 2 ways of care: standard care without hearing aid versus standard care with hearing aid. Secondary outcomes are the evaluation of the hearing and the tinnitus, the evaluation of the patients' satisfaction at the end of the study, and the evaluation of the patients' adherence to hearing aid in case of ototoxicity due to platinum-based chemotherapy.

Results: The study protocol has been opened and is actively recruiting participants. The protocol was launched on November 23, 2023, and data collection is ongoing and will be completed once all patients have completed the protocol. At least 27 patients have been recruited to date. The date of publication of the results is not yet known.

Conclusions: The PROTOTOX study aims at demonstrating that the huge impact of platinum-based chemotherapy on hearing abilities must be managed to maintain the patients' quality of life. Hearing aid is the solution experimented here.