Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jan 21, 2025
Date Accepted: Aug 7, 2025
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 (acronym: PROTOTOX).
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, ringing in the ears, and decreased hearing acuity. Those side effects can have a major impact on the quality of life of patients and are not often considered after treatment.
Objective:
The 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 two treatments: standard management without equipment versus standard management with equipment.
Methods:
PROTOTOX is an open pilot prospective monocentric study executed through collaboration of the Institut de Cancérologie de Lorraine (non-profit comprehensive cancer institute). 52 patients undergoing platinum-based chemotherapy and presenting with hypoacusis will be included and followed by an ear, nose and throat specialist. The follow-up will embrace audiometric tests, and then, with the informed consent of the patient, his/her inclusion in the study, with or without hearing aid (group 1 and 2). The primary outcome of this study is to compare the quality of life of the patients undergoing platinum-based chemotherapy presenting with hypoacusis according to two 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’ adhesion to hearing aid in case of ototoxicity due to platinum-based chemotherapy.
Results:
Experiments are ongoing, and patients continue to be included.
Conclusions:
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. Clinical Trial: n°ID-RCB: 2023-A02141-44 dated of 23/11/2023
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