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Completed

NCT Number: NCT03400709

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

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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Key information

Conditions

Cisplatin Adverse Reaction Chemically-Induced Disorders Drug-Related Side Effects and Adverse Reactions Ear Diseases Hearing Loss Ototoxic Otorhinolaryngologic Diseases Ototoxicity Pathologic Processes Pathological Conditions, Signs and Symptoms Radiation Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Daniel Munoz

Santiago, Santiago Metropolitan, 7160166, Chile

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

N Acetylcysteine

Drug

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

Placebo oral tablet

Drug

Placebo treatment

Primary outcomes

  1. Hearing threshold

    Time frame: Baseline.

    High frequencies pure tone average

  2. Hearing threshold

    Time frame: up to 4th week of chemoradiotherapy

    High frequencies pure tone average

  3. Hearing threshold

    Time frame: through study completion, an average of 3 months

    High frequencies pure tone average

Sponsors and collaborators

Lead sponsor

Hospital San Juan de Dios, Santiago

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jan 17, 2018
Registry last updated
Jan 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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