Cisplatin Adverse ReactionNCT03400709
Protective Role of N-acetylcisteine From Cisplatin-induced Ototoxicity in Patients With Head and Neck Cancer
A study testing N Acetylcysteine in people with Cisplatin Adverse Reaction and Hearing Loss Ototoxic, run by Hospital San Juan de Dios, Santiago at 1 site in Chile.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cisplatin Adverse Reaction, Hearing Loss Ototoxic
- What is being tested?
- N Acetylcysteine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteChile
- Study dates
- Nov 2015to Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults Patients with Head and Neck Squamous Cell carcinoma requiring Chemoradiotherapy including Cisplatin.
Who cannot join
- Conductive Hearing Loss
- SNHL with >= 40db PTA
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Protective Role of N-acetylcisteine From Cisplatin-induced Ototoxicity in Patients With Head and Neck Cancer. A Randomized, Placebo Controlled Clinical Trial
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.
- Conditions
- Cisplatin Adverse Reaction, Hearing Loss Ototoxic
- Being tested
- N Acetylcysteine, Placebo Oral Tablet
- Keywords
- Cisplatin, Ototoxicity, N-acetylcisteine
- Medical subject headings
- Ototoxicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N AcetylcysteineDrug
Oral administration of drug, before, during and after Chemoradiotherapy including Cisplatin.
Placebo Oral TabletDrug
Placebo treatment
| Study group | Role | What they receive |
|---|---|---|
| N-acetylcisteine group | Experimental | Not described Receives: Drug: N Acetylcysteine |
| Control group | Placebo comparator | Not described Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hearing threshold
High frequencies pure tone average
Measured: Baseline.
Hearing threshold
High frequencies pure tone average
Measured: up to 4th week of chemoradiotherapy
Hearing threshold
High frequencies pure tone average
Measured: through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2018
- Study startNov 2015
- Primary completionJun 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cisplatin Adverse ReactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital San Juan de Dios, Santiago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Munoz MD, MSc., Hospital San Juan de Dios, Santiago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03400709
- Sponsor's protocol ID
- 123606
- Status last verified
- Jan 2018
- First submitted
- 27 Dec 2017
- Last updated
- 17 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protective Role of N-acetylcisteine From Cisplatin-induced Ototoxicity in Patients With Head and Neck Cancer. A Randomized, Placebo Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03400709
- Acronym / sponsor ID
- 123606
- Conditions
- Cisplatin Adverse Reaction, Hearing Loss Ototoxic
- Keywords
- Cisplatin, Ototoxicity, N-acetylcisteine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Hospital San Juan de Dios, SantiagoUniversity, hospital or other
- Study start
- Nov 2015 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 17 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| N-acetylcisteine group | Experimental | Drug: N Acetylcysteine |
| Control group | Placebo comparator | Drug: Placebo Oral Tablet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults Patients with Head and Neck Squamous Cell carcinoma requiring Chemoradiotherapy including Cisplatin.
Key exclusion criteria (2 listed)
- Conductive Hearing Loss
- SNHL with >= 40db PTA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N AcetylcysteineOral administration of drug, before, during and after Chemoradiotherapy including Cisplatin. | Drug | N-acetylcisteine group |
| Placebo Oral TabletPlacebo treatment | Drug | Control group |
Primary outcome
Hearing threshold
Time frame: Baseline.
High frequencies pure tone average
Hearing threshold
Time frame: up to 4th week of chemoradiotherapy
High frequencies pure tone average
Hearing threshold
Time frame: through study completion, an average of 3 months
High frequencies pure tone average
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing N Acetylcysteine in people with Cisplatin Adverse Reaction and Hearing Loss Ototoxic, run by Hospital San Juan de Dios, Santiago at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hearing threshold (time frame: Baseline.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2018.