Who is sponsoring NCT05936034?

NCT05936034 is sponsored by Institut de Cancérologie de Lorraine.

What drugs are being tested in NCT05936034?

Interventions in NCT05936034: Patients suffering from chemotherapy-induced ototoxicity, Patients suffring from chemotherapy-induced ototoxicity wearing hearing aids.

What condition does NCT05936034 study?

NCT05936034 studies Cancer, Ototoxicity, Drug-Induced, Quality of Life, Hearing Disorders.

Is NCT05936034 still recruiting?

NCT05936034 is currently recruiting now. Last updated 28 November 2025.

Last reviewed 2025-11-28 · How we verify

NCT05936034: PROTOTOX

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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.

Recruiting now NA Last updated 28 November 2025

What this trial tests

NA trial testing Patients suffering from chemotherapy-induced ototoxicity in Cancer in 52 participants. Currently enrolling.

Timeline

4 January 2024

Primary endpoint
4 September 2027

4 July 2028

Quick facts

Lead sponsor	Institut de Cancérologie de Lorraine
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	52
Start date	4 January 2024
Primary completion	4 September 2027
Estimated completion	4 July 2028
Sites	1 location across France

Drugs / interventions tested

Patients suffering from chemotherapy-induced ototoxicity
Patients suffring from chemotherapy-induced ototoxicity wearing hearing aids

Conditions studied

Cancer — all drugs for Cancer →
Ototoxicity, Drug-Induced — all drugs for Ototoxicity, Drug-Induced →
Quality of Life — all drugs for Quality of Life →
Hearing Disorders — all drugs for Hearing Disorders →

Sponsor

Institut de Cancérologie de Lorraine — full company profile →

Who can join

18 and older, any sex, with Cancer or Ototoxicity, Drug-Induced. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

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.
Mastronicola R, Kayser E, Fernandez Y, Dolivet G. · · 2025 · PMID 41071987 · DOI 10.2196/71562

Verify or expand the search:

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05936034 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Institut de Cancérologie de Lorraine
Last refreshed: 28 November 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05936034.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing