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

NCT03400709 — Not applicable, Completed, 45 participants, Hospital San Juan de Dios, Santiago

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

Registry	NCT03400709
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, prevention
Enrollment	45 (Actual)
Sponsor	Hospital San Juan de Dios, Santiago (Other)
Conditions	Cisplatin Adverse Reaction, Hearing Loss Ototoxic
Interventions	N Acetylcysteine, Placebo Oral Tablet (Drug)
Dates	start 2015-11-01, primary completion 2017-06-01, completion 2017-11-01, first posted 2018-01-17, last updated 2018-01-17
Locations	1 site in Chile

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
N-acetylcisteine group	Experimental	Drug: N Acetylcysteine
Control group	Placebo comparator	Drug: Placebo Oral Tablet

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

+Outcome measures

Primary outcomes

Hearing threshold [Baseline.]: High frequencies pure tone average
Hearing threshold [up to 4th week of chemoradiotherapy]: High frequencies pure tone average
Hearing threshold [through study completion, an average of 3 months]: High frequencies pure tone average

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

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

Exclusion Criteria:

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

+Locations (1)

Facility	City	Country	Status
Daniel Munoz	Santiago, Santiago Metropolitan	Chile

My Notes

Public

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