NCT05146050

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
107

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2021

Completed
18 days until next milestone

First Posted

Study publicly available on registry

December 6, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

December 8, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

February 9, 2022

Status Verified

February 1, 2022

Enrollment Period

12 months

First QC Date

November 18, 2021

Last Update Submit

February 8, 2022

Conditions

Nasopharyngeal Carcinoma

Keywords

Nasopharyngeal CarcinomaOlfactory change

Outcome Measures

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.

    1.5 years

Secondary Outcomes (1)

  • Change inSubjective olfactory function

    1.5 years

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

nasopharyngeal carcinoma patients

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Guangzhou, Guangdong, 510060, China

RECRUITING

Related Publications (4)

  • 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.

    PMID: 10579662BACKGROUND

  • 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.

    PMID: 12105785BACKGROUND

  • 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.

    PMID: 16226328BACKGROUND

  • 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.

    PMID: 26931794BACKGROUND

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNasopharyngeal NeoplasmsPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

Central Study Contacts

Haiqiang Mai, Dr

CONTACT

86-20-8734-3643maihq@mail.sysu.edu.cn

Qiuyan Chen, Dr

CONTACT

86-20-8734-3380chenqy@mail.sysu.edu.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of the Department of Nasopharyngeal Carcinoma

Study Record Dates

First Submitted

November 18, 2021

First Posted

December 6, 2021

Study Start

December 8, 2021

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

February 9, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)