Olfactory Change After Chemo-radiotherapy for Nasopharyngeal Carcinoma

NCT ID: NCT05146050

Last Updated: 2022-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

107 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-08

Study Completion Date

2022-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Nasopharyngeal Carcinoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

* 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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Hai-Qiang Mai,MD,PhD

Director of the Department of Nasopharyngeal Carcinoma

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Haiqiang Mai, Dr

Role: CONTACT

86-20-8734-3643

Qiuyan Chen, Dr

Role: CONTACT

86-20-8734-3380

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Haiqiang Mai, MD,Ph.D

Role: primary

86-20-8734-3643

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 10579662 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12105785 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16226328 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26931794 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2021-FXY-446

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

99mTc-H7ND SPECT/CT Imaging in NSCLC
NCT05999214 RECRUITING NA