Clinical trial NCT00381771: Prevalence of Salivary Hypofunction in Patients With Globus Pharyngeus
Official title: Prevalence of Salivary Hypofunction in Patients With Globus Pharyngeus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Globus Pharyngeus
Keywords: Globus Pharyngeus
Xerostomia
Salivary Hypofunction
Pharyngoxerosis
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2006-09-28
Enrollment: 340
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Globus phryngeus patients (complaining foreign body sensation in the throat, but not having true mass lesions)

Brief summary: It is well known that 'globus sensation in throat' is caused by the chronic irritation and inflammation of oral, pharyngeal, or laryngeal mucosa, such as laryngopharyngeal reflux and chronic postnasal drip.

Xerostomia and pharyngoxerosis due to salivary hypofunction also proved to induce the mucosal change of the oral cavity and pharynx.

However, no previous studies have documented the prevalence of salivary hypofunction in patients with globus pharyngeus.

Through this clinical investigation, we hypothesized that the salivary hypofunction might be one of the leading cause of globus pharyngeus.

Detailed description: Subjects: patients with symptoms of globus pharyngeus

Globus symptom scoring: 0(mild) to 5(severe)

Subjective symptom analysis by "Standard Table for Xerostomia and Pharyngoxerosis"

Subjective physical finding analysis by "Standard Table for Xerostomia and Pharyngoxerosis"

Objective analysis of Salivary function by 99m-Tc Salivary scintigraphy

--\> Define the prevalence of salivary hypofunction in patients with globus pharyngeus (Primary end point)

Subsequent analysis (Secondary end point)

1. Group 1: Globus patients with objective salivary hypofunction
2. Group 2: Globus patients with normal salivary function

Intervention: Active management for xerostomia (Moisturizing, Gargling, Humidification, Massage of salivary gland, Stimulant of salivary secretion, Artificial saliva)

Evaluation of the change of globus symptoms after active management of xerostomia between the Group 1 and Group 2 (at 1 months, at 3 months after the initiation of intervention)

Eligibility criteria: Inclusion Criteria:

* Subjects with globus pharyngeus symptoms

Exclusion Criteria:

* Subjects with tumors in oral cavity, oropharynx, nasopharynx, hypopharynx, which may cause globus symptoms
* subjects, who do not undergo the endoscopic exam for the upper aerodigestive tract including oral cavity, oropharynx, nasopharynx, hypopharynx.
* subjects, who take medications that may have potential effect on the mucosa of the upper aerodigestive tract including oral cavity, oropharynx, nasopharynx, hypopharynx.
* subjects with poor medical performance (\<70%)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center, Dept of Otorhinolaryngology-Head and Neck Surgery
name: Han-Sin Jeong, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Baek CH, Chung MK, Choi JY, So YK, Son YI, Jeong HS. Role of salivary function in patients with globus pharyngeus. Head Neck. 2010 Feb;32(2):244-52. doi: 10.1002/hed.21176.