Olfactory Change After Chemo-radiotherapy for Nasopharyngeal Carcinoma

Nasopharyngeal Carcinoma Clinical Trial

Official title:

Changes and Influence Factors of Olfactory Function After Chemo-radiotherapy for Locally Advanced Nasopharyngeal Carcinoma: a Prospective Observational Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05146050
• Other study ID #: 2021-FXY-446
• Status: Recruiting
• Start date: December 8, 2021
• Est. completion date: December 1, 2022

Study information

• Verified date: February 2022
• Source: Sun Yat-sen University
• Contact: Haiqiang Mai, Dr
• Phone: 86-20-8734-3643
• Email: maihq[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 107
• Est. completion date: December 1, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma

Locations

Country	Name	City	State
China	Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (4)

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. — View Citation

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. — View Citation

Hölscher T, Seibt A, Appold S, Dörr W, Herrmann T, Hüttenbrink KB, Hummel T. Effects of radiotherapy on olfactory function. Radiother Oncol. 2005 Nov;77(2):157-63. Epub 2005 Oct 13. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change inSubjective olfactory function	The Questionnaire of Olfactory Disorders (QOD) will be used during the assessment from baseline to 1 year after radiotherapy.	1.5 years