Clinical trial NCT05146050: Olfactory Change After Chemo-radiotherapy for Nasopharyngeal Carcinoma
Official title: Changes and Influence Factors of Olfactory Function After Chemo-radiotherapy for Locally Advanced Nasopharyngeal Carcinoma: a Prospective Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Nasopharyngeal Carcinoma
Keywords: Nasopharyngeal Carcinoma
Olfactory change
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2021-12-06
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: nasopharyngeal carcinoma patients

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in bjective olfactory function
timeFrame: 1.5 years
Secondary outcomes:
measure: Change inSubjective olfactory function
timeFrame: 1.5 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
References:
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. doi: 10.1080/026990599121106.
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. doi: 10.1053/ajot.2002.123436.
citation: 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.
citation: 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.