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

Cisplatin Adverse Reaction Clinical Trial

Official title:

Protective Role of N-acetylcisteine From Cisplatin-induced Ototoxicity in Patients With Head and Neck Cancer. A Randomized, Placebo Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03400709
• Other study ID #: 123606
• Status: Completed
• Phase: N/A
• First received: December 27, 2017
• Last updated: January 14, 2018
• Start date: November 2015
• Est. completion date: November 2017

Study information

• Verified date: January 2018
• Source: Hospital San Juan de Dios, Santiago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: November 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Conductive Hearing Loss

• SNHL with >= 40db PTA

Related Conditions & MeSH terms

• Cisplatin Adverse Reaction
• Head and Neck Neoplasms
• Hearing Loss
• Hearing Loss Ototoxic

Intervention

Drug:
• N Acetylcysteine
Oral administration of drug, before, during and after Chemoradiotherapy including Cisplatin.
• Placebo Oral Tablet
Placebo treatment

Locations

Country	Name	City	State
Chile	Daniel Munoz	Santiago	Metropolitana

Sponsors (1)

Lead Sponsor	Collaborator
Hospital San Juan de Dios, Santiago

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hearing threshold	High frequencies pure tone average	Baseline.
Primary	Hearing threshold	High frequencies pure tone average	up to 4th week of chemoradiotherapy
Primary	Hearing threshold	High frequencies pure tone average	through study completion, an average of 3 months