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Parotid NeoplasmsNCT05738395

Symptoms of Frey's Syndrome

An observational study of Parotid Neoplasms, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Parotid Neoplasms
What is being tested?
Questions
How many people
20 participants
Where
1 siteItaly
Study dates
1 Nov 2020to 1 Nov 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Adult, Older adult

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

Who may be able to join

  • Clinical diagnosis of Frey's syndrome

Who cannot join

  • Patients already treated for Frey syndrome, with any therapy
  • History of radiation therapy of the head-neck district
  • Patients affected by neurologic diseases

Trial locations and contacts

1 site in 1 country.

Italy1 site, 1 recruiting
  • Maria Raffaella Marchese

    Roma, 00198

    Maria Raffaella Marchese, 3391144556, raffaellamarchese@gmail.com

    Recruiting

Other trials in Italy

About this study

Official title: Typical and Atypical Symptoms of Frey's Syndrome: a Pilot Study

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)
Being tested
Questions
Medical subject headings
Parotid Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • QuestionsDiagnostic test

    Questions

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: five years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Feb 2023
  2. Study start1 Nov 2020
  3. Primary completion1 Nov 2025 (estimated)
  4. Study completion1 Nov 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05738395
Sponsor's protocol ID
3494
Status last verified
Feb 2023
First submitted
1 Feb 2023
Last updated
22 Feb 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Parotid Neoplasms, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To describe the prevalence and the severity of typical and atypical signs and symptoms of Frey's syndrom (time frame: five years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2023.

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