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

Hospital San Juan de Dios, Santiago

Status: Completed

Conditions: Cisplatin Adverse Reaction; Hearing Loss Ototoxic

Treatments: Drug: Placebo Oral Tablet; Drug: N Acetylcysteine

Study type: Interventional

Funder types: Other

Identifiers

NCT03400709

123606

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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45 participants in 2 patient groups, including a placebo group

N-acetylcisteine group

Experimental group

Treatment:

Drug: N Acetylcysteine

Control group

Placebo Comparator group

Treatment:

Drug: Placebo Oral Tablet