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.
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
- Recruiting
Maria Raffaella Marchese
Roma, 00198
Maria Raffaella Marchese, 3391144556, raffaellamarchese@gmail.com
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)
- Conditions
- Parotid Neoplasms
- 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.
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.
- First posted22 Feb 2023
- Study start1 Nov 2020
- Primary completion1 Nov 2025 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parotid NeoplasmsStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marchese Maria Raffaella, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Typical and Atypical Symptoms of Frey's Syndrome: a Pilot Study
- ClinicalTrials.gov ID
- NCT05738395
- Acronym / sponsor ID
- 3494
- Conditions
- Parotid Neoplasms
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 22 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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)
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients affected by Frey's syndrome after parotidectomy for parotid gland tumors
Key inclusion criteria (1 listed)
- Clinical diagnosis of Frey's syndrome
Key exclusion criteria (3 listed)
- Patients already treated for Frey syndrome, with any therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionsQuestions | Diagnostic test | – |
Primary outcome
To describe the prevalence and the severity of typical and atypical signs and symptoms of Frey's syndrom
Time frame: five years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
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.