The impact of mouth radiotherapy dose distribution on the occurrence and severity of radiotherapy-induced oral mucositis

Not Applicable

Recruiting

• Conditions: Mucositis; C06.405.205.798

• Registration Number: RBR-6dj5y4
• Lead Sponsor: Instituto do Câncer do Estado de São Paulo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-20
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Patients with oral squamous cell carcinomas (C02; C02.1; C04; C05; C10), who concluded a pre-radiotherapy oral compliance protocol with the ICESP Oncological Dentistry Service. Patients on an oral exclusive diet prior to radiotherapy and who will use oral stent during radiotherapy sessions. Patients should also be on the Institutional protocol Oncological Dentistry Service, with daily follow-up at the laser therapy clinic (photobiomodulation).

Exclusion Criteria

Will be excluded from our protocol patients with:
- Squamous cell carcinomas in non-oral topographies;
- Interruption of radiotherapy treatment;
- Karnofsky scales below 40%;
- Performing diet via nasogastric tube and gastrostomy before radiotherapy
-Patients edentulous and not candidates for the use of oral stents according to the Institutional protocol;
- Patients with non adherence to the laser therapy protocol, or up to 5 consecutive absences in outpatient laser therapy appoinment follow up.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>To characterize and validate the radiosensitivity and its correlation with development and progression of oral mucositis by means of in vivo dosimetry

Secondary Outcome Measures

Name	Time	Method
To perform a comparative analysis between radiosensitivity to oral mucosal site associated with tumor topography of mouth tumors