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

NCT03400709 | Completed DMC

• 1 other identifier: 123606
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cisplatin Adverse Reaction; Hearing Loss Ototoxic

Keywords

Cisplatin; Ototoxicity; N-acetylcisteine

Outcome Measures

Primary Outcomes (3)

• Hearing threshold

  High frequencies pure tone average

  Baseline.

• Hearing threshold

  High frequencies pure tone average

  up to 4th week of chemoradiotherapy

• Hearing threshold

  High frequencies pure tone average

  through study completion, an average of 3 months

Study Arms (2)

N-acetylcisteine group

EXPERIMENTAL

Drug: N Acetylcysteine

Control group

PLACEBO COMPARATOR

Drug: Placebo Oral Tablet

Interventions

N Acetylcysteine DRUG

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

N-acetylcisteine group

Placebo Oral Tablet DRUG

Placebo treatment

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Conductive Hearing Loss
• SNHL with \>= 40db PTA

Sponsors & Collaborators

• Hospital San Juan de Dios, Santiago: lead

Study Sites (1)

Daniel Munoz

Santiago, Santiago Metropolitan, 7160166, Chile

Location

MeSH Terms

Conditions

Ototoxicity

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Ear Diseases; Otorhinolaryngologic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Otolaryngologist, Clinical Epidemiologist.

Study Record Dates

• First Submitted: December 27, 2017
• First Posted: January 17, 2018
• Study Start: November 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: November 1, 2017
• Last Updated: January 17, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)