Post-radiotherapy Rhinosinusitis in Children

Pediatric Cancer Clinical Trial

— PRRSC  

Official title:

Evaluation of Chronic Rhinosinusitis in Children Managed for Cervicofacial Mesenchymal Malignancy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05454163
• Other study ID #: 2021_0549
• Secondary ID: 2022-A00422-41
• Status: Not yet recruiting
• Start date: October 2022
• Est. completion date: October 2025

Study information

• Verified date: July 2022
• Source: University Hospital, Lille
• Contact: Pierre Fayoux, MD,PhD
• Phone: 0320445962
• Email: pierre.fayoux[@]chu-lille.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Chronic rhinosinusitis (CRS) is a frequent complication of facial cancer treatment, mainly related to radiotherapy. However, while radiological involvement is frequent, clinical expression seems less important. Few studies have investigated the incidence of this condition in the pediatric population while its evolution seems to be very chronic even if a partial improvement may occur with time. Our objective is therefore to study the impact of CSR in children treated for cancer of the cervicofacial region, to evaluate its incidence and medium-term evolution in order to determine whether it is necessary to set up a specific follow-up in these patients. The clinical impact of CSR is assessed by a specific SNOT 22 questionnaire in children treated for a head-neck mesenchymal malignancy in comparison with a control population consisting of children treated for a mesenchymal malignancy of non-head-neck location.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 55
• Est. completion date: October 2025
• Est. primary completion date: October 2025
• Gender: All
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

• Study population: all patients under 18 years of age managed for a head neck mesenchymal cancer between January 1, 2018 and December 31, 2024
• Control population: all patient under 1 years of age managed for non -head neck mesenchymal cancer between January 1, 2018 and December 31, 2024

Exclusion Criteria:

• Patients with hematological tumors;
• Patients with mucociliary pathologies or proven allergic rhinitis before the diagnosis of cancer
• Patients who have required surgical treatment that has removed more than half of the sinus cavities
• Tumor recurrence at the time of inclusion
• Sinus surgery between the last radiological check-up and inclusion
• Administrative reasons: inability to receive informed information.

Related Conditions & MeSH terms

• Chronic Sinusitis
• Pediatric Cancer
• Sinusitis

Intervention

Other:
• SNOT 22 questionnaire
22 items, score between 0 and 5; sum, minimum = 0, maximum = 110; higher score = higher impact on quality of life)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Lille	Centre Oscar Lambret

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Impact of CRS in pediatric patients by Sino-Nasal Outcome Test-22 (SNOT 22)		>1 year to <4 years after the end of oncologic treatment
Secondary	Incidence of CRS in pediatric patients after head neck mesenchymal cancer management		1 year after the end of the oncologic treatment
Secondary	Correlation between SNOT 22 and clinical assessment by PADORES score		>1 year to <4 years after the end of oncologic treatment
Secondary	Correlation between SNOT 22 and clinical assessment by lund-kennedy score		>1 year to <4 years after the end of oncologic treatment
Secondary	Correlation between SNOT 22 and radiological assessment by Lund-Mackay score		>1 year to <4 years after the end of oncologic treatment
Secondary	Radiological evolution of CRS by Lund-Mackay score		>1 year to <4 years after the end of oncologic treatment