Back to resultsProtective Role of N-acetylcisteine From Cisplatin-induced Ototoxicity in Patients With Head and Neck Cancer
Primary Purpose
Cisplatin Adverse Reaction, Hearing Loss Ototoxic
Status
Completed
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
N Acetylcysteine
Placebo Oral Tablet
Sponsored by
About this trial
This is an interventional prevention trial for Cisplatin Adverse Reaction focused on measuring Cisplatin, Ototoxicity, N-acetylcisteine
Eligibility 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
Sites / Locations
- Daniel Munoz
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
N-acetylcisteine group
Control group
Arm Description
Outcomes
Primary Outcome Measures
Hearing threshold
High frequencies pure tone average
Hearing threshold
High frequencies pure tone average
Hearing threshold
High frequencies pure tone average
Secondary Outcome Measures
Full Information
NCT ID
NCT03400709
First Posted
December 27, 2017
Last Updated
January 14, 2018
Sponsor
Hospital San Juan de Dios, Santiago
1. Study Identification
Unique Protocol Identification Number
NCT03400709
Brief Title
Protective Role of N-acetylcisteine From Cisplatin-induced Ototoxicity in Patients With Head and Neck Cancer
Official Title
Protective Role of N-acetylcisteine From Cisplatin-induced Ototoxicity in Patients With Head and Neck Cancer. A Randomized, Placebo Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
November 2015 (Actual)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
November 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital San Juan de Dios, Santiago
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cisplatin Adverse Reaction, Hearing Loss Ototoxic
Keywords
Cisplatin, Ototoxicity, N-acetylcisteine
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
N-acetylcisteine group
Arm Type
Experimental
Arm Title
Control group
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
N Acetylcysteine
Intervention Description
Oral administration of drug, before, during and after Chemoradiotherapy including Cisplatin.
Intervention Type
Drug
Intervention Name(s)
Placebo Oral Tablet
Intervention Description
Placebo treatment
Primary Outcome Measure Information:
Title
Hearing threshold
Description
High frequencies pure tone average
Time Frame
Baseline.
Title
Hearing threshold
Description
High frequencies pure tone average
Time Frame
up to 4th week of chemoradiotherapy
Title
Hearing threshold
Description
High frequencies pure tone average
Time Frame
through study completion, an average of 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Daniel Munoz
City
Santiago
State/Province
Metropolitana
ZIP/Postal Code
7160166
Country
Chile
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Protective Role of N-acetylcisteine From Cisplatin-induced Ototoxicity in Patients With Head and Neck Cancer
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