Otoprotection in cancer treatment.

Phase 1

• Conditions: Cisplatin ototoxicity; Therapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]; MedDRA version: 18.1Level: PTClassification code 10033109Term: OtotoxicitySystem Organ Class: 10013993 - Ear and labyrinth disorders

• Registration Number: EUCTR2015-003953-16-ES
• Lead Sponsor: ÁREA DE ATENCIÓN INTEGRADA DE ALBACETE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02-03
• Last Update Posted: 1 October 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 23

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

?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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified