Clinical Trial

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.

Study acronym: PROTOTOX
Recruiting
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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.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2023-06-29; most recent amendment 2025-11-21.
Status change: Not Yet Recruiting → Recruiting 2024-01-05
Trial Details
NCT Number NCT05936034
Lead Sponsor Institut de Cancérologie de Lorraine
Conditions Cancer, Ototoxicity, Drug-Induced, Quality of Life, Hearing Disorders
Enrollment 52 participants
Start Date 2024-01-04
Primary Completion 2027-09-04 (estimated)
Study Completion 2028-07-04 (estimated)
Updated on ClinicalTrials.gov 2025-11-28