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Protective Role of N-acetylcisteine From Cisplatin-induced Ototoxicity in Patients With Head and Neck Cancer

NCT ID: NCT03400709

Last Updated: 2018-01-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2017-11-30

Brief Summary

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Introduction. Cisplatin-induced ototoxicity is a very frequent event and its consequences can cause a lot of deterioration in patients. Early diagnosis is essential because it would allow the appropriate implementation of strategies to reduce its effect. Among these N-acetylcysteine, an antioxidant agent that has shown otoprotective effect. Study design. Randomized, parallel design and placebo controlled clinical trial. Methods. Patients with head and neck cancer who require treatment with cisplatin were enrolled in 2 branches: a control group that receives a placebo and experimental group that receives the drug. High-frequency audiometries (6 - 16 KHz) are performed before, during and after the treatment finalization.

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Detailed Description

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Conditions

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Cisplatin Adverse Reaction Hearing Loss Ototoxic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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N-acetylcisteine group

Group Type EXPERIMENTAL

N Acetylcysteine

Intervention Type DRUG

Oral administration of drug, before, during and after Chemoradiotherapy including Cisplatin.

Control group

Group Type PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type DRUG

Placebo treatment

Interventions

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N Acetylcysteine

Oral administration of drug, before, during and after Chemoradiotherapy including Cisplatin.

Intervention Type DRUG

Placebo Oral Tablet

Placebo treatment

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adults Patients with Head and Neck Squamous Cell carcinoma requiring Chemoradiotherapy including Cisplatin.

Exclusion Criteria

* Conductive Hearing Loss
* SNHL with \>= 40db PTA
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital San Juan de Dios, Santiago

OTHER

Sponsor Role lead

Responsible Party

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Daniel Munoz MD, MSc.

Otolaryngologist, Clinical Epidemiologist.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Daniel Munoz

Santiago, Santiago Metropolitan, Chile

Site Status

Countries

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Chile

Other Identifiers

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123606

Identifier Type: -

Identifier Source: org_study_id

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