Evaluation of Laser Therapy in the Prevention and Treatment of Oral Irritations Due to Cancer Treatment

Phase 4

Recruiting

• Conditions: Oral Mucositis; C06.405.205.798

• Registration Number: RBR-92md93
• Lead Sponsor: niversidade Federal de Pernambuco

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-01-18
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

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

Inclusion Criteria

Group 1: Patients with head and neck neoplasms undergoing radiotherapy;Group 2: Patients with head and neck neoplasms undergoing radiochemotherapy;Group 3: Patients with neoplasias of the gastrointestinal tract under chemotherapeutic treatment (Fluorpyrimidine).

Exclusion Criteria

Patients younger than 18 years;Presence of oral ulcerations or erosions;Cognitive deficits;Simultaneous participation in another clinical study;In long-term treatment with photosensitizing agents.Difficulty opening the mouth, such as trismus or maxillo-mandibular block.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ower prevalence of oral mucositis, comparing the proportions between the experimental and control subgroup, a significance of 5% and a 95% confidence interval will be adopted. According to normality tests, parametric or non-parametric tests will be adopted To compare the proportions.

Secondary Outcome Measures

Name	Time	Method
Minor severity and pain of Oral Mucositis. The degree of Oral Mucositis will be assessed according to World Health Organization classification criteria and in relation to oral pain, patients will be assessed subjectively according to a Visual Analogue Scale. According to normality tests, parametric or non-parametric tests will be used to compare the means, a significance of 5% and a confidence interval of 95% will be adopted.