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Status unknownNCT05146050Updated Feb 9, 2022

Olfactory Change After Chemo-radiotherapy for Nasopharyngeal Carcinoma

An observational study in Nasopharyngeal Carcinoma, sponsored by Sun Yat-sen University. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-02-09.

Sponsored by Sun Yat-sen University · Observational

The sponsor has not verified this record recently (last verified Feb 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
107
Ages
18 Years to 70 Years
Sex
All
01

Study summary

This is an observational cohort study aimed to explore the changes of olfactory function at multiple time points from baseline to 1 year after radiotherapy among the local advanced nasopharyngeal carcinoma patients.

Read the detailed description

Newly-diagnosed patients with stage III or IV non-metastatic Nasopharyngeal Carcinoma (AJCC 8th) will be recruited. Olfactory function of consecutive patients with nasopharyngeal carcinoma was assessed prospectively before treatment and serially up to 1 year after radiotherapy by the Sniffin' Sticks olfactory function test and by The Questionnaire of Olfactory Disorders (QOD) as well as a patient symptom visual analogue scale. The change in olfactory function and it's influence factors in NPC patients who receiving induction chemotherapy with concurrent chemoradiotherapy will be investigated.

02

Conditions studied

  • Nasopharyngeal Carcinoma

Keywords

  • Nasopharyngeal Carcinoma
  • Olfactory change
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In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's planned enrollment of 107 is below the median of 149 across 1,175 observational studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Sun Yat-sen University is the lead sponsor of 1,644 studies on the registry; 602 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

nasopharyngeal carcinoma patients

Inclusion criteria

  • Age 18-70, regardless of sex.
  • Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, type of WHO II or III, clinical stage III-IVa (according to the 8th American Joint Committee on Cancer [AJCC] edition).
  • ECOG (Eastern Cooperative Oncology Group) score: 0-1.
  • Patients receiving induction chemotherapy with concurrent chemoradiotherap.
  • Patients must sign informed consent and be willing, and well understood the objective and procedure of this study.

Exclusion criteria

Exclusion Criteria:

  • Women in pregnancy or lactation.
  • Patients who received additional treatment during the observation period due to disease progression.
  • Patients with significantly lower heart, liver, lung, kidney and bone marrow function.
  • Patient with severe medical condition.
  • with a condition that could cause olfactory dysfunction, such as septum deviation, nasal polyposis, nasopharyngeal necrosis, congenital olfactory dysfunction, septum surgery, head trauma, chronic rhinosinusitis, allergic rhinitis, or psychiatric or neurological disorders, such as Parkinson's, MS and Alzheimer's disease, or long history of psychiatric drug, corticosteroids or other drug that may affect olfactory function.
  • Not able to return for evaluation of olfactory function or follow-up (language, practical implementation, mental condition)
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
107 participants (estimated)
Target follow-up
1 Year
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. Change in bjective olfactory function

    Objective olfactory function was assessed was assessed prospectively before treatment and serially up to 1 year after radiotherapy by TDI-score according to the Sniffin' Sticks olfactory function test.

    Time frame: 1.5 years

Secondary outcomes

  1. Change inSubjective olfactory function

    The Questionnaire of Olfactory Disorders (QOD) will be used during the assessment from baseline to 1 year after radiotherapy.

    Time frame: 1.5 years

07

Study locations

1 of 1 sites recruiting
  • Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center
    Guangzhou, Guangdong 510060, China
    Recruiting
08

References and documents

Publications

  • Hua MS, Chen ST, Tang LM, Leung WM. Olfactory function in patients with nasopharyngeal carcinoma following radiotherapy. Brain Inj. 1999 Nov;13(11):905-15. doi: 10.1080/026990599121106. PubMed 10579662 ↗
  • Ho WK, Kwong DL, Wei WI, Sham JS. Change in olfaction after radiotherapy for nasopharyngeal cancer--a prospective study. Am J Otolaryngol. 2002 Jul-Aug;23(4):209-14. doi: 10.1053/ajot.2002.123436. PubMed 12105785 ↗
  • Holscher T, Seibt A, Appold S, Dorr W, Herrmann T, Huttenbrink KB, Hummel T. Effects of radiotherapy on olfactory function. Radiother Oncol. 2005 Nov;77(2):157-63. doi: 10.1016/j.radonc.2005.09.015. Epub 2005 Oct 13. PubMed 16226328 ↗
  • Galletti B, Santoro R, Mannella VK, Caminiti F, Bonanno L, De Salvo S, Cammaroto G, Galletti F. Olfactory event-related potentials: a new approach for the evaluation of olfaction in nasopharyngeal carcinoma patients treated with chemo-radiotherapy. J Laryngol Otol. 2016 May;130(5):453-61. doi: 10.1017/S0022215116000761. Epub 2016 Mar 2. PubMed 26931794 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 9, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05146050
Lead sponsor
Sun Yat-sen University
Responsible party
Hai-Qiang Mai,MD,PhD (Director of the Department of Nasopharyngeal Carcinoma, Sun Yat-sen University) — Principal investigator
First posted
Dec 6, 2021
Start date
Dec 8, 2021
Primary completion
Dec 1, 2022 (estimated)
Completion
Dec 1, 2022 (estimated)
Last update
Feb 9, 2022

Study contacts

Haiqiang Mai, Dr
Contact
maihq@mail.sysu.edu.cn
86-20-8734-3643
Qiuyan Chen, Dr
Contact
chenqy@mail.sysu.edu.cn
86-20-8734-3380

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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