Nasopharyngeal CarcinomaNCT05330169
Hearing Impairment of Nasopharyngeal Carcinoma
An observational study of Nasopharyngeal Carcinoma, run by Guangxi Medical University at 1 site in China.
Trial summary
This observational cohort study was aimed to evaluate the hearing toxicity at multiple time points from baseline to 1 year after radical chemoradiotherapy among nasopharyngeal carcinoma patients. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Nasopharyngeal Carcinoma
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2022to 31 Dec 2023
- Phase
- Observational
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: nasopharyngeal carcinoma patients
Who may be able to join
- Histologically confirmed non-keratinizing nasopharyngeal carcinoma(WHO II/III).
- About to undergo radical chemoradiotherapy with intensity-modulated radiotherapy (IMRT).
- Eastern Cooperative Oncology Group performance status≤1.
- Adequate marrow function: neutrocyte count≥1.5×10e9/L, hemoglobin
- ≥90g/L, and platelet count≥100×10e9/L.
- Alanine Aminotransferase (ALT)/Aspartate Aminotransferase (AST)
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- ≤2.5×upper limit of normal (ULN), and bilirubin≤ 1.5×ULN.
- Adequate renal function: creatinine clearance rate≥ 60 ml/min (Cockcroft-Gault formula).
- Patients must be informed of the investigational nature of this study and give written informed consent.
Who cannot join
- Age > 60 or < 18.
- Receiving additional targeted therapy or immunotherapy except for radiotherapy and chemotherapy.
- With a condition that could cause hearing impairment, such as ear canal cerumen blockage, ear canal foreign body blockage, cholesteatoma, tympanic membrane perforation, cholesteatoma otitis media, middle ear granulation tissue growth, inner ear labyrinthitis, sudden nerve deafness, Meniere's disease, acoustic neuroma, and so on.
- Patients who received aminoglycoside antibiotics or macrocyclic lipid antibiotics (such as streptomycin, gentamicin, kanamycin, neomycin, tobramycin, minocycline, erythromycin, roxithromycin, etc.) orally or intravenously within 30 days before treatment.
- Patients with hearing loss at the baseline（except for those with conductive hearing loss diagnosed by at least two deputy chief physicians as nasopharyngeal carcinoma-related）
- Patients who received additional treatment during the observation period due to disease progression.
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- Pregnant or breastfeeding.
- Patients with prior malignancy who have received systemic chemotherapy or head and neck radiotherapy.
- Any other condition, including symptomatic heart failure, unstable angina, myocardial infarction, active infection requiring systemic therapy, mental illness or domestic/social factors, deemed by the investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interferes with the interpretation of the results.
Trial locations and contacts
1 site in 1 country.
China1 site
the First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021
About this study
Official title: Prospective Observational Cohort Study to Evaluate Hearing Toxicity Before and After Chemoradiotherapy in Patients With Nasopharyngeal Carcinoma
This observational cohort study was aimed to evaluate the hearing toxicity at multiple time points from baseline to 1 year after radical chemoradiotherapy among nasopharyngeal carcinoma patients.
Read the detailed description
With the development of radiotherapeutic techniques and equipment as well as advances in treatment modalities, the 5-year overall survival of patients with non-disseminated NPC has exceeded 80%. However, the incidence of hearing toxicity did not decrease significantly compared with the past. The hearing loss remains the second most common toxicity after xerostomia. Audiometry, acoustic impedance testing, eustachian tube pressure measurements, and distortion product otoacoustic emissions will be used to compare hearing before treatment and up to 1 year after radical chemoradiotherapy. The related factors affecting the hearing of NPC patients will also be investigated and explored.
- Conditions
- Nasopharyngeal Carcinoma
- Keywords
- Hearing Toxicity, Chemoradiotherapy
- Medical subject headings
- Nasopharyngeal Carcinoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Hearing level (decibel)
We will use pure tone audiometry to access the hearing level (decibel) before treatment and serially up to 1 year after radical chemoradiotherapy.
Measured: up to 16 months
The ratio of distortion product otoacoustic emission(DPOAE) failure
We will use distortion product otoacoustic emission(DPOAE) to access the hearing before treatment and serially up to 1 year after radical chemoradiotherapy.
Measured: up to 16 months
Secondary outcomes (2)
The ratio of Eustachian tube dysfuction(ETD)
We will use eustachian tube pressure measurement to access the eustachian tube function before treatment and serially up to 1 year after radical chemoradiotherapy.
Measured: up to 16 months
Tympanogram type
We will use acoustic impedance tests to access the tympanogram type before treatment and serially up to 1 year after radical chemoradiotherapy.
Measured: up to 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study start1 Sep 2022
- Primary completion31 Dec 2022
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal CarcinomaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangxi Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kai Hu, Guangxi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05330169
- Sponsor's protocol ID
- GuangxiMUHK3
- Status last verified
- Jul 2024
- First submitted
- 28 Mar 2022
- Last updated
- 17 Jul 2024
- Results posted
- No
- 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 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Cohort Study to Evaluate Hearing Toxicity Before and After Chemoradiotherapy in Patients With Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT05330169
- Acronym / sponsor ID
- GuangxiMUHK3
- Conditions
- Nasopharyngeal Carcinoma
- Keywords
- Hearing Toxicity, Chemoradiotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Guangxi Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 15 Apr 2022 (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.
This observational cohort study was aimed to evaluate the hearing toxicity at multiple time points from baseline to 1 year after radical chemoradiotherapy among nasopharyngeal carcinoma patients.
Detailed description
With the development of radiotherapeutic techniques and equipment as well as advances in treatment modalities, the 5-year overall survival of patients with non-disseminated NPC has exceeded 80%. However, the incidence of hearing toxicity did not decrease significantly compared with the past. The hearing loss remains the second most common toxicity after xerostomia. Audiometry, acoustic impedance testing, eustachian tube pressure measurements, and distortion product otoacoustic emissions will be used to compare hearing before treatment and up to 1 year after radical chemoradiotherapy. The related factors affecting the hearing of NPC patients will also be investigated and explored.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- nasopharyngeal carcinoma patients
Key inclusion criteria (9 listed)
- Histologically confirmed non-keratinizing nasopharyngeal carcinoma(WHO II/III).
- About to undergo radical chemoradiotherapy with intensity-modulated radiotherapy (IMRT).
- Eastern Cooperative Oncology Group performance status≤1.
- Adequate marrow function: neutrocyte count≥1.5×10e9/L, hemoglobin
- ≥90g/L, and platelet count≥100×10e9/L.
Key exclusion criteria (9 listed)
- Age > 60 or < 18.
- Receiving additional targeted therapy or immunotherapy except for radiotherapy and chemotherapy.
- With a condition that could cause hearing impairment, such as ear canal cerumen blockage, ear canal foreign body blockage, cholesteatoma, tympanic membrane perforation, cholesteatoma otitis media, middle ear granulation tissue growth, inner ear labyrinthitis, sudden nerve deafness, Meniere's disease, acoustic neuroma, and so on.
- Patients who received aminoglycoside antibiotics or macrocyclic lipid antibiotics (such as streptomycin, gentamicin, kanamycin, neomycin, tobramycin, minocycline, erythromycin, roxithromycin, etc.) orally or intravenously within 30 days before treatment.
- Patients with hearing loss at the baseline（except for those with conductive hearing loss diagnosed by at least two deputy chief physicians as nasopharyngeal carcinoma-related）
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hearing level (decibel)
Time frame: up to 16 months
We will use pure tone audiometry to access the hearing level (decibel) before treatment and serially up to 1 year after radical chemoradiotherapy.
The ratio of distortion product otoacoustic emission(DPOAE) failure
Time frame: up to 16 months
We will use distortion product otoacoustic emission(DPOAE) to access the hearing before treatment and serially up to 1 year after radical chemoradiotherapy.
2 secondary outcomes
The ratio of Eustachian tube dysfuction(ETD)
Time frame: up to 16 months
Tympanogram type
Time frame: up to 16 months
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 Jul 2024.
- 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?
An observational study of Nasopharyngeal Carcinoma, run by Guangxi Medical University at 1 site in China.
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 9 inclusion and 9 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 Jul 2024. 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 China. 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. 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 level (decibel) (time frame: up to 16 months). The study lists 2 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 Jul 2024.