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

Last updated: January 14, 2018
Sponsor: Hospital San Juan de Dios, Santiago
Overall Status: Completed

Phase

N/A

Condition

Hearing Impairment

Hearing Loss

Deafness

Treatment

N/A

Clinical Study ID

NCT03400709
123606
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • Conductive Hearing Loss

  • SNHL with >= 40db PTA

Study Design

Total Participants: 45
Study Start date:
November 01, 2015
Estimated Completion Date:
November 30, 2017

Connect with a study center

  • Daniel Munoz

    Santiago, Metropolitana 7160166
    Chile

    Site Not Available

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