Trial | NCT03400709  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    45
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.
Study Started
Nov 30
2015
Primary Completion
Jun 30
2017
Study Completion
Nov 30
2017
Last Update
Jan 17
2018

Drug N Acetylcysteine

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

Drug Placebo Oral Tablet

Placebo treatment

N-acetylcisteine group Experimental

Control group Placebo Comparator

Criteria 

Inclusion Criteria:

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

Exclusion Criteria:

Conductive Hearing Loss
SNHL with >= 40db PTA
No Results Posted