Nasopharyngeal CarcinomaNCT02505672
Vestibular Function After Chemoradiotherapy for Nasopharyngeal Carcinoma
An observational study of Nasopharyngeal Carcinoma, run by Rabin Medical Center at 1 site in Israel.
Trial summary
Nasopharyngeal carcinoma (NPC) is usually treated with chemoradiotherapy. While the effects of this treatment on cochlear function is well characterized, its effect on vestibular function is not well studied. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nasopharyngeal Carcinoma
- What is being tested?
- Chemoradiotherapy for nasopharyngeal carcinoma
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2016to Dec 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with biopsy-proven nasopharyngeal carcinoma who are planned to undergo chemoradiotherapy.
Who may be able to join
- Age 18 years or older.
- Biopsy-proven NPC.
- About to undergo chemoradiotherapy with intensity-modulated radiotherapy (IMRT).
Who cannot join
- Pregnancy.
- Prior vestibular dysfunction.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Department of Otolaryngology, Rabin Medical Center
Petah Tikva
Yotam Shkedy, MD, +972-3-9376458, yotamyo@clalit.org.il
Yotam Shkedy, MD
About this study
Nasopharyngeal carcinoma (NPC) is usually treated with chemoradiotherapy. While the effects of this treatment on cochlear function is well characterized, its effect on vestibular function is not well studied.
In this study the investigators will study the vestibular function of 50 patients undergoing chemoradiotherapy for NPC both before and after treatment in order to better define its effects. All patients will undergo a validated questionnaire (dizziness handicap index), posturography, audiometry and vestibular-evoked myogenic potentials.
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- Chemoradiotherapy for nasopharyngeal carcinoma
- Keywords
- Vestibular function, chemoradiotherapy
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chemoradiotherapy for nasopharyngeal carcinomaRadiation
Note that this is standard care for NPC and patients are not assigned to different intervention groups. All patients in the study will receive the same treatment (chemoradiotherapy) and will be observed for changes in vestibular function.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Patients older than 18 who are planned to undergo chemoradiotherapy for nasopharyngeal carcinoma. Receives: Radiation: Chemoradiotherapy for nasopharyngeal carcinoma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective dizziness and vestibular dysfunction using the dizziness handicap index
Measured: 6 months after completion of treatment
Hearing level using standard audiometry
Measured: 6 months after completion of treatment
Objective vestibular function using posturography
Measured: 6 months after completion of treatment
Vestibular saccular function using vestibular-evoked myogenic potentials
Measured: 6 months after completion of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2015 (estimated)
- Study startAug 2016
- Primary completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yotam shkedy, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02505672
- Sponsor's protocol ID
- 0361-14-RMC
- Status last verified
- Apr 2016
- First submitted
- 18 Jul 2015
- Last updated
- 19 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Colaco RJ, Betts G, Donne A, Swindell R, Yap BK, Sykes AJ, Slevin NJ, Homer JJ, Lee LW. Nasopharyngeal carcinoma: a retrospective review of demographics, treatment and patient outcome in a single centre. Clin Oncol (R Coll Radiol). 2013 Mar;25(3):171-7. doi: 10.1016/j.clon.2012.10.006. Epub 2013 Jan 18.
PubMed 23337060Tuan JK, Ha TC, Ong WS, Siow TR, Tham IW, Yap SP, Tan TW, Chua ET, Fong KW, Wee JT. Late toxicities after conventional radiation therapy alone for nasopharyngeal carcinoma. Radiother Oncol. 2012 Sep;104(3):305-11. doi: 10.1016/j.radonc.2011.12.028. Epub 2012 Jan 24.
PubMed 22280806Zhang L, Chen QY, Liu H, Tang LQ, Mai HQ. Emerging treatment options for nasopharyngeal carcinoma. Drug Des Devel Ther. 2013;7:37-52. doi: 10.2147/DDDT.S30753. Epub 2013 Feb 1.
PubMed 23403548Wei Y, Zhou T, Zhu J, Zhang Y, Sun M, Ding X, Wang D, Li H, Li B. Long-term outcome of sensorineural hearing loss in nasopharyngeal carcinoma patients: comparison between treatment with radiotherapy alone and chemoradiotherapy. Cell Biochem Biophys. 2014 Jul;69(3):433-7. doi: 10.1007/s12013-014-9814-x.
PubMed 24510513Lin C, Lin SW, Weng SF, Lin YS. Risk of developing sudden sensorineural hearing loss in patients with nasopharyngeal carcinoma: a population-based cohort study. Head Neck. 2014 Feb;36(2):203-8. doi: 10.1002/hed.23278. Epub 2013 Jun 18.
PubMed 23780872Tsang RK, Kwong DL, Ho AC, To VS, Ho WK, Wei WI. Long-term hearing results and otological complications of nasopharyngeal carcinoma patients: comparison between treatment with conventional two-dimensional radiotherapy and intensity-modulated radiotherapy. ORL J Otorhinolaryngol Relat Spec. 2012;74(4):228-33. doi: 10.1159/000341096. Epub 2012 Aug 17.
PubMed 22907195Chao WY, Tseng HZ, Tsai ST. Caloric response and postural control in patients with nasopharyngeal carcinoma after radiotherapy. Clin Otolaryngol Allied Sci. 1998 Oct;23(5):439-41. doi: 10.1046/j.1365-2273.1998.00170.x.
PubMed 9800080Chen PR, Hsu LP, Tu CE, Young YH. Radiation-induced oscillopsia in nasopharyngeal carcinoma patients. Int J Radiat Oncol Biol Phys. 2005 Feb 1;61(2):466-70. doi: 10.1016/j.ijrobp.2004.05.016.
PubMed 15667968Wu CC, Young YH, Ko JY. Effect of irradiation on vestibular evoked myogenic potentials in nasopharyngeal carcinoma survivors. Head Neck. 2003 Jun;25(6):482-7. doi: 10.1002/hed.10215.
PubMed 12784240Young YH, Ko JY, Sheen TS. Postirradiation vertigo in nasopharyngeal carcinoma survivors. Otol Neurotol. 2004 May;25(3):366-70. doi: 10.1097/00129492-200405000-00027.
PubMed 15129119Hsin CH, Chen TH, Young YH, Liu WS. Comparison of otologic complications between intensity-modulated and two-dimensional radiotherapies in nasopharyngeal carcinoma patients. Otolaryngol Head Neck Surg. 2010 Nov;143(5):662-8. doi: 10.1016/j.otohns.2010.07.012.
PubMed 20974336Kaplan DM, Friger M, Racover NK, Peleg A, Kraus M, Puterman M. [The Hebrew dizziness handicap inventory]. Harefuah. 2010 Nov;149(11):697-700, 750, 749. Hebrew.
PubMed 21250408
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vestibular Function After Chemoradiotherapy for Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT02505672
- Acronym / sponsor ID
- 0361-14-RMC
- Conditions
- Nasopharyngeal Carcinoma
- Keywords
- Vestibular function, chemoradiotherapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Dec 2016 (estimated)
- First posted
- 22 Jul 2015 (estimated)
- 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.
Nasopharyngeal carcinoma (NPC) is usually treated with chemoradiotherapy. While the effects of this treatment on cochlear function is well characterized, its effect on vestibular function is not well studied.
In this study the investigators will study the vestibular function of 50 patients undergoing chemoradiotherapy for NPC both before and after treatment in order to better define its effects. All patients will undergo a validated questionnaire (dizziness handicap index), posturography, audiometry and vestibular-evoked myogenic potentials.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Radiation: Chemoradiotherapy for nasopharyngeal carcinomaPatients older than 18 who are planned to undergo chemoradiotherapy for nasopharyngeal carcinoma. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with biopsy-proven nasopharyngeal carcinoma who are planned to undergo chemoradiotherapy.
Key inclusion criteria (3 listed)
- Age 18 years or older.
- Biopsy-proven NPC.
- About to undergo chemoradiotherapy with intensity-modulated radiotherapy (IMRT).
Key exclusion criteria (2 listed)
- Pregnancy.
- Prior vestibular dysfunction.
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 |
|---|---|---|
| Chemoradiotherapy for nasopharyngeal carcinomaNote that this is standard care for NPC and patients are not assigned to different intervention groups. All patients in the study will receive the same treatment (chemoradiotherapy) and will be observed for changes in vestibular function. | Radiation | Study group |
Primary outcome
Subjective dizziness and vestibular dysfunction using the dizziness handicap index
Time frame: 6 months after completion of treatment
Hearing level using standard audiometry
Time frame: 6 months after completion of treatment
Objective vestibular function using posturography
Time frame: 6 months after completion of treatment
Vestibular saccular function using vestibular-evoked myogenic potentials
Time frame: 6 months after completion of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2016.
- Background: PubMed 23337060Colaco RJ, Betts G, Donne A, Swindell R, Yap BK, Sykes AJ, Slevin NJ, Homer JJ, Lee LW. Nasopharyngeal carcinoma: a retrospective review of demographics, treatment and patient outcome in a single centre. Clin Oncol (R Coll Radiol). 2013 Mar;25(3):171-7. doi: 10.1016/j.clon.2012.10.006. Epub 2013 Jan 18.
- Background: PubMed 22280806Tuan JK, Ha TC, Ong WS, Siow TR, Tham IW, Yap SP, Tan TW, Chua ET, Fong KW, Wee JT. Late toxicities after conventional radiation therapy alone for nasopharyngeal carcinoma. Radiother Oncol. 2012 Sep;104(3):305-11. doi: 10.1016/j.radonc.2011.12.028. Epub 2012 Jan 24.
- Background: PubMed 23403548Zhang L, Chen QY, Liu H, Tang LQ, Mai HQ. Emerging treatment options for nasopharyngeal carcinoma. Drug Des Devel Ther. 2013;7:37-52. doi: 10.2147/DDDT.S30753. Epub 2013 Feb 1.
- Background: PubMed 24510513Wei Y, Zhou T, Zhu J, Zhang Y, Sun M, Ding X, Wang D, Li H, Li B. Long-term outcome of sensorineural hearing loss in nasopharyngeal carcinoma patients: comparison between treatment with radiotherapy alone and chemoradiotherapy. Cell Biochem Biophys. 2014 Jul;69(3):433-7. doi: 10.1007/s12013-014-9814-x.
- Background: PubMed 23780872Lin C, Lin SW, Weng SF, Lin YS. Risk of developing sudden sensorineural hearing loss in patients with nasopharyngeal carcinoma: a population-based cohort study. Head Neck. 2014 Feb;36(2):203-8. doi: 10.1002/hed.23278. Epub 2013 Jun 18.
- Background: PubMed 22907195Tsang RK, Kwong DL, Ho AC, To VS, Ho WK, Wei WI. Long-term hearing results and otological complications of nasopharyngeal carcinoma patients: comparison between treatment with conventional two-dimensional radiotherapy and intensity-modulated radiotherapy. ORL J Otorhinolaryngol Relat Spec. 2012;74(4):228-33. doi: 10.1159/000341096. Epub 2012 Aug 17.
- Background: PubMed 9800080Chao WY, Tseng HZ, Tsai ST. Caloric response and postural control in patients with nasopharyngeal carcinoma after radiotherapy. Clin Otolaryngol Allied Sci. 1998 Oct;23(5):439-41. doi: 10.1046/j.1365-2273.1998.00170.x.
- Background: PubMed 15667968Chen PR, Hsu LP, Tu CE, Young YH. Radiation-induced oscillopsia in nasopharyngeal carcinoma patients. Int J Radiat Oncol Biol Phys. 2005 Feb 1;61(2):466-70. doi: 10.1016/j.ijrobp.2004.05.016.
- Background: PubMed 12784240Wu CC, Young YH, Ko JY. Effect of irradiation on vestibular evoked myogenic potentials in nasopharyngeal carcinoma survivors. Head Neck. 2003 Jun;25(6):482-7. doi: 10.1002/hed.10215.
- Background: PubMed 15129119Young YH, Ko JY, Sheen TS. Postirradiation vertigo in nasopharyngeal carcinoma survivors. Otol Neurotol. 2004 May;25(3):366-70. doi: 10.1097/00129492-200405000-00027.
- Background: PubMed 20974336Hsin CH, Chen TH, Young YH, Liu WS. Comparison of otologic complications between intensity-modulated and two-dimensional radiotherapies in nasopharyngeal carcinoma patients. Otolaryngol Head Neck Surg. 2010 Nov;143(5):662-8. doi: 10.1016/j.otohns.2010.07.012.
- Background: PubMed 21250408Kaplan DM, Friger M, Racover NK, Peleg A, Kraus M, Puterman M. [The Hebrew dizziness handicap inventory]. Harefuah. 2010 Nov;149(11):697-700, 750, 749. Hebrew.
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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.
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 Rabin Medical Center at 1 site in Israel.
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 3 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: status not confirmed, as of the sponsor's last update on 19 Apr 2016. 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 Israel. 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 Yotam Shkedy, MD (+972-3-9376458, yotamyo@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective dizziness and vestibular dysfunction using the dizziness handicap index (time frame: 6 months after completion of treatment). The study lists 4 primary outcomes in all. 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 NCT02505672, which also lists 12 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 19 Apr 2016.