NCT05738395

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2020

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

February 1, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 22, 2023

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

February 22, 2023

Status Verified

February 1, 2023

Enrollment Period

5 years

First QC Date

February 1, 2023

Last Update Submit

February 11, 2023

Conditions

Parotid Neoplasms

Outcome Measures

Primary Outcomes (1)

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

    five years

Interventions

QuestionsDIAGNOSTIC_TEST

Questions

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Clinical diagnosis of Frey's syndrome

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maria Raffaella Marchese

Roma, 00198, Italy

RECRUITING

MeSH Terms

Conditions

Parotid Neoplasms

Condition Hierarchy (Ancestors)

Salivary Gland NeoplasmsMouth NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNeoplasmsMouth DiseasesStomatognathic DiseasesParotid DiseasesSalivary Gland Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor, PhD

Study Record Dates

First Submitted

February 1, 2023

First Posted

February 22, 2023

Study Start

November 1, 2020

Primary Completion

November 1, 2025

Study Completion

November 1, 2025

Last Updated

February 22, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)