Ignite Creation Date:
2024-05-06 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05738395
Status:
RECRUITING
Last Update Posted:
2023-02-22
First Post:
2023-02-01
Brief Title:
Symptoms of Freys Syndrome
Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Organization:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study Overview
Official Title:
Typical and Atypical Symptoms of Freys Syndrome a Pilot Study
Status:
RECRUITING
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this observational study is to describe the prevalence of typical and atypical signs and symptoms of Freys syndrome the affected areas and the severity of each symptomsign
Participants will be asked will asked about
Presence or the absence of a gustatory sweating b gustatory flushing c gustatory itching d paresthesia e pain
Grade of severity a absence b mild c moderate d almost severe e severe
Affected area a preauricular b retroauricolar c temporal d retrangulomandibular e cheek
Participants will be asked will asked about
Presence or the absence of a gustatory sweating b gustatory flushing c gustatory itching d paresthesia e pain
Grade of severity a absence b mild c moderate d almost severe e severe
Affected area a preauricular b retroauricolar c temporal d retrangulomandibular e cheek
Detailed Description:
The Freys syndrome classically appears with sweating and hyperemia that occur almost immediately after tasting foods particularly spicy ones in the distribution of the auriculotemporal nerve region hence it is also called auriculotemporal syndrome The synkinetic mechanism for Freys syndrome supposes an aberrant regeneration of the parasympathetic fibers because they normally innervate the parotid gland and after losing their parotid targets they regenerate to innervate the facial skin vessels and sweat glands As a consequence this results in a local vasodilatation gustatory flushing and localized sweating gustatory sweating of the sympathetically void skin in response to mastication and salivation Drummond PD 2002 Rustemeyer J et al 2008 Neumann A e al 2011 Gardner WJ et al 1956 The etiology may be traumatic parotidectomy abscess drainage bullet wound Rouyer J 1959 Botkin S 1875 or nontraumatic autonomic neuropathy in diabetes mellitus herpes zoster infection metabolic diseases etc New GB 1922 The most frequent etiologic factor is undoubtedly the parotidectomy Parotid gland tumors are among the most common neoplasms in the head and neck region and a variable portion Linder TE et al 1997 Bussu F et al 2011 May JS 1989 Ranging from 17 up to 100 of patients who underwent parotidectomy are affected by Freys syndrome depending whether or not they performed specific test Grossly half of them notice symptoms and feel the gustatory sweating Around 13-23 of patients consider their symptoms troublesome and severe Laskawi RT et al 1996 May JS 1989 Potential negative social and psychologic implications of this condition can be significant and treatment ranging from topical agents glycopyrrolate to local injections of botulinum toxin Botox to surgical intervention ie temporoparietal fascia flap interposition should be offered to patients Hays LL 1982 Moreover the Freys syndrome in addition to the gustatory sweating and flushing almost constant with a variable severity can be associated with other atypical symptoms The sensation of heat itch and pain in the distribution of the auriculotemporal nerve were not mentioned as accompanying symptoms in the original description of the syndrome by Frey Frey L 1923 The pain is an uncommon finding reported in less than 10 of cases Bednarek J et al 1976 It can be an early symptom and may remain the only one Usually described as constant aching or burning De Benedettis et al 1990 reported two cases in which pain was the predominant symptom Gustatory itch was described anecdotally by Ricks et al 2010 as a sequela of superficial parotidectomy a neurophysiological pathway involving acetylcoline and histamine has been proposed to explain this phenomenon It cannot be ruled out that the presence of pain and itch is under-reported in the literature because they are generally not predominant and the patient is often not specifically asked about A systematic comprehensive assessment of Frey related complaints is currently missing Most studies describe a single manifestation or the predominant ones basing simply on the absence or presence of symptoms and signs Jansen S et al 2017 without a graduation of them
Study design and setting This will be a no-profit observational cross-sectional pilot study Patients addressed to the Otolaryngology Unit of our Institution with a diagnosis of Frey syndrome will be consecutively enrolled if matching inclusion criteria The expected duration of the study will be two years
Objectives
Primary
To describe the prevalence of typical and atypical signs and symptoms of Freys syndrome the affected areas and the severity of each symptomsign Secondary
To describe the global severity of the Freys syndrome in the group of the study
To describe the severity of Freys syndrome in relation to the history data etiology age sex comorbidities surgical procedure age of onset
Study design and setting This will be a no-profit observational cross-sectional pilot study Patients addressed to the Otolaryngology Unit of our Institution with a diagnosis of Frey syndrome will be consecutively enrolled if matching inclusion criteria The expected duration of the study will be two years
Objectives
Primary
To describe the prevalence of typical and atypical signs and symptoms of Freys syndrome the affected areas and the severity of each symptomsign Secondary
To describe the global severity of the Freys syndrome in the group of the study
To describe the severity of Freys syndrome in relation to the history data etiology age sex comorbidities surgical procedure age of onset
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None