Cisplatin Adverse Reaction, Hearing Loss Ototoxic
Conditions
Keywords
Cisplatin, Ototoxicity, N-acetylcisteine
Brief 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.
Interventions
DRUGN Acetylcysteine
Oral administration of drug, before, during and after Chemoradiotherapy including Cisplatin.
DRUGPlacebo Oral Tablet
Placebo treatment
Sponsors
Hospital San Juan de Dios, Santiago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults Patients with Head and Neck Squamous Cell carcinoma requiring Chemoradiotherapy including Cisplatin.
Exclusion criteria
* Conductive Hearing Loss * SNHL with \>= 40db PTA
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hearing threshold | Baseline. | High frequencies pure tone average |
Countries
Chile
Outcome results
None listed