Otoprotection in cancer treatment.

A Phase IIIb study of the efficacy of dexamethasone in irreversible hearing loss prevention in subjects with Ototoxic Oncological Treatment. Otoprotection in cancer treatment.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-003953-16-ES

Enrollment

Registered

2016-02-03

Start date

2016-04-05

Completion date

Unknown

Last updated

2018-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cisplatin ototoxicity MedDRA version: 18.1 Level: PT Classification code 10033109 Term: Ototoxicity System Organ Class: 10013993 - Ear and labyrinth disorders

Interventions

Trade Name: Fortecortin® 40mg Solución Inyectable Product Name: Dexametasone Pharmaceutical Form: Solution for injection INN or Proposed INN: DEXAMETHASONE SODIUM PHOSPHATE Other descriptive name: DEX

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Men and women ?18 years of age -Patients from oncology department of Complejo Hospitalario Universitario de Albacete who are starting chemotherapy treatment with cisplatin. -Patients without any previous of hearing impairment except age-related pathology. -Patients able to return for all clinic visits andcomplete all study-related procedures -Signed Informed Consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 23 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 23

Exclusion criteria

Exclusion criteria: ? Retrocochlear hearing loss. ? Meniere's disease ? Autoimmune Inner Ear Disease ? Fluctuating hearing loss ? History of sudden sensory neural hearing loss. ? Previous radiation therapy to the head and neck region. ? Patients with pathology of the middle ear ? Participation in any clinical trial at the same time

Design outcomes

Primary

Measure	Time frame
Main Objective: Investigate the potential protective effect of intratympanic dexamethasone administration on cisplatin-induced ototoxicity in patients with malignan neoplasm, through pure tone audiometry and Video Heald Impulse Test.;Secondary Objective: -Change in score of pure tone audiometry in conventional frequency ranges (125 Hz-3000 Hz-8000 Hz) -Change in adverse events related to vestibulo-ocular reflex associated with cisplatin through Video Head Impulse Test, before and after Intratympanic dexamethasone. -Change in adverse events related to tinnitus associated with cisplatin through Tinnitus Handicap Inventory (THI), before and after Intratympanic dexamethasone;Primary end point(s): ? Liminal Tonal Audiometry (LTA): from 125 Hz to 8000 Hz, including systematically 3000 Hz ? Assessment of vestibulo-ocular reflex through VHIT (Video Head Impulse Test);Timepoint(s) of evaluation of this end point: The evaluation of both endpoints will be in the Screening visit, follow-up visits and End of Study Visit. The study visits, both the number and frequency of visits, are not predefined by protocol, depends exclusively on the number and frequency of cycles of cisplatin prescribed by the oncologist.	—

Measure

Time frame

Main Objective: Investigate the potential protective effect of intratympanic dexamethasone administration on cisplatin-induced ototoxicity in patients with malignan neoplasm, through pure tone audiometry and Video Heald Impulse Test.;Secondary Objective: -Change in score of pure tone audiometry in conventional frequency ranges (125 Hz-3000 Hz-8000 Hz) -Change in adverse events related to vestibulo-ocular reflex associated with cisplatin through Video Head Impulse Test, before and after Intratympanic dexamethasone. -Change in adverse events related to tinnitus associated with cisplatin through Tinnitus Handicap Inventory (THI), before and after Intratympanic dexamethasone;Primary end point(s): ? Liminal Tonal Audiometry (LTA): from 125 Hz to 8000 Hz, including systematically 3000 Hz ? Assessment of vestibulo-ocular reflex through VHIT (Video Head Impulse Test);Timepoint(s) of evaluation of this end point: The evaluation of both endpoints will be in the Screening visit, follow-up visits and End of Study Visit. The study visits, both the number and frequency of visits, are not predefined by protocol, depends exclusively on the number and frequency of cycles of cisplatin prescribed by the oncologist.

—

Secondary

Measure	Time frame
Secondary end point(s): Tinnitus handicap Inventory Questionnaire;Timepoint(s) of evaluation of this end point: The evaluation of this endpoint will be in the Screening visit and End of Study Visit.	—

Countries

Spain

Contacts

Public ContactClinical Trials Unit

ÁREA DE ATENCIÓN INTEGRADA DE ALBACETE

bperezz@sescam.jccm.es

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026