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Nasopharyngeal CarcinomaNCT06170021

Occurrence of Radiation-induced Otitis Media in Nasopharyngeal Carcinoma Patients After Intensity Modulated Radiotherapy

An observational study of Nasopharyngeal Carcinoma, run by Sun Yat-sen University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is an observational cohort study to investigate the incidence of radiation-induced otitis media, changes in tubal function and hearing in newly diagnosed nasopharyngeal carcinoma patients without metastasis at multiple time points from baseline to 1 year after radiotherapy. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Nasopharyngeal Carcinoma
How many people
215 participants
Where
1 siteChina
Study dates
18 Dec 2023to 6 Dec 2025
How long will I take part?
1 Year
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Newly diagnosed non-metastatic nasopharyngeal carcinoma patients.

Who may be able to join

  • Age 18-70, regardless of sex.
  • ECOG (Eastern Cooperative Oncology Group) score: 0-1.
  • Patients must sign informed consent and be willing, and well understood the objective and procedure of this study.
  • Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, type of WHO II or III, clinical stage I-IVa (according to the 8th American Joint Committee on Cancer [AJCC] edition.
  • No radiotherapy or chemotherapy was administered before enrollment.
  • Expected survival time ≥ 6 months.

Who cannot join

  • Women in pregnancy or lactation.
  • Patients with significantly lower heart, liver, lung, kidney, bone marrow function and other severe medical condition.
  • Prior to radiotherapy, there is a clear underlying disease of the eustachian tube or other ear diseases.
  • Patients with otitis media before radiotherapy and have no improvement at the end of radiotherapy.
  • Patients with history of middle ear, nasal or nasopharyngeal surgery on the affected side.
  • Patients combined with congenital cleft palate and other craniofacial abnormalities.
Show all 11Show fewer
  • Patients with histologically confirmed keratinizing nasopharyngeal carcinoma, type of WHO I.
  • Patients with recurrence and distant metastasis.
  • Patients with radiotherapy or chemotherapy before.
  • Age < 18 or age > 70.
  • Patients who changed their initial treatment regimen during the observation period due to disease progression (including tumor residual after radiotherapy, tumor recurrence, and new distant metastases).

Trial locations and contacts

1 site in 1 country.

Haiqiang Mai, Dr contact

86-20-8734-3643

maihq@mail.sysu.edu.cn

Qiuyan Chen, Dr contact

86-20-8734-3380

chenqy@mail.sysu.edu.cn

China1 site, 1 recruiting

  • Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

    Haiqiang Mai, MD,Ph.D, 86-20-8734-3643, maihq@mail.sysu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: Effect of Irradiation Dose to Eustachian Tube and Surrounding Auditory Organs on the Occurrence of Radiation-induced Otitis Media in Nasopharyngeal Carcinoma Patients During Intensity Modulated Radiotherapy Era: A Prospective Cohort Study

This is an observational cohort study to investigate the incidence of radiation-induced otitis media, changes in tubal function and hearing in newly diagnosed nasopharyngeal carcinoma patients without metastasis at multiple time points from baseline to 1 year after radiotherapy.

Read the detailed description

Patients with newly diagnosed non-metastatic nasopharyngeal carcinoma (AJCC 8th) will be recruited. The incidence of radiation-induced otitis media, eustachian tube function and hearing level in nasopharyngeal carcinoma patients will be prospectively evaluated by magnetic resonance imaging, otoscope, pure tone audiometry, acoustic immittance test and the Eustachian Tube Dysfunction Questionnaire (ETDQ-7) before treatment and serially up to 1 year after radiotherapy. The quality of life of patients will be evaluated before treatment and serially up to 1 year after radiotherapy. The incidence of radiation-induced otitis media, the changes of eustachian tube function and hearing level, together with the influencing factors, in nasopharyngeal carcinoma patients after induction chemotherapy and concurrent chemoradiotherapy will be investigated.

Keywords
Nasopharyngeal Carcinoma, Radiation-induced Otitis Media
Medical subject headings
Nasopharyngeal Carcinoma

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of radiation-induced otitis media

    Incidence of radiation-induced otitis media will be assessed prospectively before treatment and serially up to 1 year after radiotherapy by magnetic resonance imaging, otoscope, acoustic immittance test and pure tone audiometry.

    Measured: 1 year

Secondary outcomes (5)

  1. Effect of the irradiation dose of eustachian tube, tympanum, cochlea, internal auditory tract and vestibule on the occurrence of radiation-induced otitis media

    The occurrence of radiation-induced otitis media will be assessed prospectively before treatment and serially up to 1 year after radiotherapy by magnetic resonance imaging, otoscope, acoustic immittance test and pure tone audiometry.

    Measured: 1 year

  2. Effect of irradiation dose in the area around of eustachian tube on the severity of ototoxicity after radiotherapy

    Severity of ototoxictiy will be assessed prospectively before treatment and serially up to 1 year after radiotherapy by magnetic resonance imaging, otoscope, acoustic immittance test, pure tone audiometry and the Eustachian Tube Dysfunction Questionnaire (ETDQ-7).

    Measured: 1 year

  3. Effect of irradiation dose of eustachian tube on hearing injury

    The injury of hearing will be assessed prospectively before treatment and serially up to 1 year after radiotherapy by acoustic immittance test and pure tone audiometry.

    Measured: 1 year

  4. Effect of different chemoradiotherapy treatment regimens on the occurrence of radiation-induced otitis media

    The occurrence of radiation-induced otitis media will be assessed prospectively before treatment and serially up to 1 year after radiotherapy by magnetic resonance imaging, otoscope, acoustic immittance test and pure tone audiometry.

    Measured: 1 year

  5. Correlation between radiation-induced otitis media and life quality after radiotherapy

    The life quality will be assessed prospectively before treatment and serially up to 1 year after radiotherapy.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Dec 2023
  2. Study start18 Dec 2023
  3. Primary completion6 Dec 2025 (estimated)
  4. Study completion6 Dec 2025 (estimated)

Resources

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
215 participants (estimated)
Target duration
1 Year
IDs, dates and publications
ClinicalTrials.gov ID
NCT06170021
Sponsor's protocol ID
2023-FXY-228
Status last verified
Aug 2024
First submitted
6 Dec 2023
Last updated
6 Aug 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Chen YP, Chan ATC, Le QT, Blanchard P, Sun Y, Ma J. Nasopharyngeal carcinoma. Lancet. 2019 Jul 6;394(10192):64-80. doi: 10.1016/S0140-6736(19)30956-0. Epub 2019 Jun 6.

    PubMed 31178151

  • Emami B, Lyman J, Brown A, Coia L, Goitein M, Munzenrider JE, Shank B, Solin LJ, Wesson M. Tolerance of normal tissue to therapeutic irradiation. Int J Radiat Oncol Biol Phys. 1991 May 15;21(1):109-22. doi: 10.1016/0360-3016(91)90171-y.

    PubMed 2032882

  • Hsin CH, Tseng HC, Lin HP, Chen TH. Post-irradiation otitis media, rhinosinusitis, and their interrelationship in nasopharyngeal carcinoma patients treated by IMRT. Eur Arch Otorhinolaryngol. 2016 Feb;273(2):471-7. doi: 10.1007/s00405-015-3518-8. Epub 2015 Jan 30.

    PubMed 25634060

  • Hsin CH, Chen TH, Liang KL, Tseng HC, Liu WS. Postirradiation otitis media with effusion in nasopharyngeal carcinoma patients treated by intensity-modulated radiotherapy. Laryngoscope. 2013 Sep;123(9):2148-53. doi: 10.1002/lary.23215. Epub 2013 Jul 8.

    PubMed 23835775

  • Yao JJ, Zhou GQ, Lin L, Zhang WJ, Peng YL, Chen L, Tang LL, Mao YP, Ma J, Sun Y. Dose-volume factors associated with ear disorders following intensity modulated radiotherapy in nasopharyngeal carcinoma. Sci Rep. 2015 Sep 1;5:13525. doi: 10.1038/srep13525.

    PubMed 26323586

  • Wang SZ, Wang WF, Zhang HY, Guo M, Hoffman MR, Jiang JJ. Analysis of anatomical factors controlling the morbidity of radiation-induced otitis media with effusion. Radiother Oncol. 2007 Dec;85(3):463-8. doi: 10.1016/j.radonc.2007.10.007. Epub 2007 Nov 19.

    PubMed 18006095

Questions about this trial

What is this clinical trial studying?

An observational study of Nasopharyngeal Carcinoma, run by Sun Yat-sen 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 6 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 6 Aug 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Haiqiang Mai, Dr (86-20-8734-3643, maihq@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of radiation-induced otitis media (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06170021, which also lists 6 linked publications.

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 6 Aug 2024.

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