Vestibular Function After Chemoradiotherapy for Nasopharyngeal Carcinoma

Nasopharyngeal Carcinoma Clinical Trial

Official title:

Vestibular Function After Chemoradiotherapy for Nasopharyngeal Carcinoma

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02505672
• Other study ID #: 0361-14-RMC
• Status: Not yet recruiting
• Phase: N/A
• First received: July 18, 2015
• Last updated: April 16, 2016
• Start date: August 2016

Study information

• Verified date: April 2016
• Source: Rabin Medical Center
• Contact: Yotam Shkedy, MD
• Phone: +972-3-9376458
• Email: yotamyo[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 years or older.

• Biopsy-proven NPC.

• About to undergo chemoradiotherapy with intensity-modulated radiotherapy (IMRT).

Exclusion Criteria:

• Pregnancy.

• Prior vestibular dysfunction.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma
• Nasopharyngeal Neoplasms

Intervention

Radiation:
• Chemoradiotherapy for nasopharyngeal carcinoma
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.

Locations

Country	Name	City	State
Israel	Department of Otolaryngology, Rabin Medical Center	Petach Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (12)

Chao 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. — View Citation

Chen 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. — View Citation

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. Review. — View Citation

Hsin 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. — View Citation

Kaplan 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. — View Citation

Lin 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. — View Citation

Tsang 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. — View Citation

Tuan 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. — View Citation

Wei 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. — View Citation

Wu 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. — View Citation

Young YH, Ko JY, Sheen TS. Postirradiation vertigo in nasopharyngeal carcinoma survivors. Otol Neurotol. 2004 May;25(3):366-70. — View Citation

Zhang 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. Review. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjective dizziness and vestibular dysfunction using the dizziness handicap index		6 months after completion of treatment	No
Primary	Hearing level using standard audiometry		6 months after completion of treatment	No
Primary	Objective vestibular function using posturography		6 months after completion of treatment	No
Primary	Vestibular saccular function using vestibular-evoked myogenic potentials		6 months after completion of treatment	No