Extra and Intraoral Low-Intensity Laser for Prevention and Treatment of Oral Lesions and Dry Mouth in Cancer patients: Double-Blind Randomized Controlled Clinical Study

Not Applicable

Recruiting

• Conditions: Stomatitis; Xerostomia; C04.588.443

• Registration Number: RBR-5p2xfzd
• Lead Sponsor: Pontifícia Universidade Católica de Campinas

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-12-19
• Last Update Posted: 23 January 2024
• Study Completion: 2024-09-30

Recruitment & Eligibility

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

Inclusion Criteria

Patients over 18 years old diagnosed with head and neck cancer will be included; Patients undergoing the first week of radiotherapy and/or chemotherapy with curative intent in the Oncology Sector of Hospital PUC-Campinas in the period from 2023 to 2024; Patients or guardians who agree and sign the Informed Consent Form

Exclusion Criteria

Patients who die during treatment (before completing the initially established sessions) will be excluded; Patients who give up oncological treatment before completion; Patients who were not in the first week of radiotherapy and/or chemoradiotherapy; Patients on palliative protocols;Patients with total loss of the maxilla or mandible as a result of the tumor; Patients who are unable to perform sialometry (difficulty spitting saliva); Patients who refuse to sign the Informed Consent Form

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
It is expected that extraoral photobiomodulation (PBM) associated with intraoral photobiomodulation will have a superior behavior than intraoral photobiomodulation in the prevention and treatment of low salivary flow and Oral Mucositis (OM) resulting from the effects of radiotherapy and/or chemotherapy of the head and neck, contributing to an improvement in quality of life. of cancer patients.

Secondary Outcome Measures

Name	Time	Method
To evaluate whether extra and intraoral photobiomodulation is superior to intraoral photobiomodulation in controlling oral mucositis and increasing salivary flow in oncology patients with head and neck cancer.