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RecruitingNCT05738395Updated Feb 22, 2023

Symptoms of Frey's Syndrome

An observational study in Parotid Neoplasms, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Recruiting at 1 site in Italy. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-02-22.

Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Observational

From the registry’s dates

  • Primary completion was expected by Nov 2025, 11 months ago, but the record still lists the study as recruiting.
  • Started Nov 2020; still recruiting 5 years 11 months later.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
20
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The goal of this observational study is to describe the prevalence of typical and atypical signs and symptoms of Frey's syndrome, the affected areas and the severity of each symptom/sign.

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
Read the detailed description

The Frey's 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 Frey's 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 Frey's 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 (i.e. temporoparietal fascia flap interposition) should be offered to patients (Hays LL, 1982). Moreover the Frey's 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 Frey's syndrome, the affected areas and the severity of each symptom/sign Secondary
  • To describe the global severity of the Frey's syndrome in the group of the study;
  • To describe the severity of Frey's syndrome in relation to the history data (etiology, age, sex, comorbidities, surgical procedure, age of onset)
02

Conditions studied

  • Parotid Neoplasms

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03

In context

Parotid Neoplasms

27 studies on the registry are indexed under Parotid Neoplasms; 7 are open to participants now.

Browse Parotid Neoplasms studies →

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 920 studies on the registry; 529 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Sampling method
Probability sample

Study population

Patients affected by Frey's syndrome after parotidectomy for parotid gland tumors

Inclusion criteria

  • Clinical diagnosis of Frey's syndrome

Exclusion criteria

Exclusion Criteria:

  • Patients already treated for Frey syndrome, with any therapy

    • History of radiation therapy of the head-neck district
    • Patients affected by neurologic diseases
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
20 participants (estimated)
Patient registry
No

Interventions

  • Diagnostic testQuestions

    Questions

06

What researchers measure

Primary outcomes

  1. To describe the prevalence and the severity of typical and atypical signs and symptoms of Frey's syndrom

    Time frame: five years

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 22, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05738395
Lead sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Responsible party
Marchese Maria Raffaella (Medical Doctor, PhD, Fondazione Policlinico Universitario Agostino Gemelli IRCCS) — Principal investigator
First posted
Feb 22, 2023
Start date
Nov 1, 2020
Primary completion
Nov 1, 2025 (estimated)
Completion
Nov 1, 2025 (estimated)
Last update
Feb 22, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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