Oral Manifestations in Children With Cancer

Overview

Before the start of the selected chemotherapy patients will be treated preventively for oral mucositis. A group will carry out the mouthwash with chlorhexidine 0.12% twice a day for five days and another will be held to damage preventive therapy (wavelength of 660nm, power 100mW and lluencia of 4 J / cm² per point, with distance of 2cm between points located on the right buccal mucosa, left buccal mucosa, hard palate, upper lip and lower lip). Patients who develop oral mucositis even after the prevention, will be divided into three groups for laser sessions with the purpose of treatment of oral mucositis. The group assignment obeyed severity of oral mucositis. Group 1 will include patients with oral mucositis grade 1. Sera used wavelength of 660nm, power 100mW and lluencia of 4 J / cm². Group 2 included patients with oral mucositis grade 2. Sera used with a wavelength of 660nm, power 100mW and lluencia of 8 J / cm². Group 3 included patients with oral mucositis grade 3 Sera used laser diode AsGaAl operating in continuous mode, with a wavelength of 790 nm, power of 100mW and fluency of 8 J / cm².

Full Title of Study: “Oral Manifestations of Leukemia and Anticancer Treatment in Childhood”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: December 2017

Detailed Description

Before the start of the selected chemotherapy patients will be treated preventively for oral mucositis. A group will carry out the mouthwash with chlorhexidine 0.12% twice a day for five days and another will be held to damage preventive therapy (wavelength of 660nm, power 100mW and lluencia of 4 J / cm² per point, with distance of 2cm between points located on the right buccal mucosa, left buccal mucosa, hard palate, upper lip and lower lip). Patients who develop oral mucositis even after the prevention, will be divided into three groups for laser sessions with the purpose of treatment of oral mucositis. The group assignment obeyed severity of oral mucositis. Group 1 will include patients with oral mucositis grade 1. Sera used wavelength of 660nm, power 100mW and lluencia of 4 J / cm². Group 2 included patients with oral mucositis grade 2. Sera used with a wavelength of 660nm, power 100mW and lluencia of 8 J / cm². Group 3 included patients with oral mucositis grade 3 Sera used laser diode AsGaAl operating in continuous mode, with a wavelength of 790 nm, power of 100mW and fluency of 8 J / cm². The assessment of oral mucositis will be held with the WHO classification: grade 0 = no mucositis; Grade I = erythema without injury; Grade II = ulcers, but can eat; Grade III = painful sores, but able to consume liquid food (nutrition), with support of analgesia; Grade IV = requires parenteral or enteral support and continuous analgesia. The patient also conduct a self-assessment of pain by visual analog scale pain quantifying 0-10 before the laser section and after the first application. Pediatric male or female, diagnosed with cancer who have not yet started cancer treatment, with otherwise healthy oral mucosa in the initial dental exam. Patients who have already started treatment for cancer under radiotherapy or presenting traumatic factors (such as braces or restorations with sharp edges), or presenting ulcers in the mucosa at the initial examination.

Interventions

  • Procedure: Laser
    • Patients who develop oral mucositis even after the prevention, will be divided into three groups for laser sessions with the purpose of treatment of oral mucositis. The group assignment obeyed severity of oral mucositis.

Arms, Groups and Cohorts

  • Experimental: mucositis grade 1, laser 660
    • Group 1 will include patients with oral mucositis grade 1. Sera used wavelength of 660nm, power 100mW and lluencia of 4 J / cm².
  • Experimental: mucositis grade 2, laser 660
    • Group 2 included patients with oral mucositis grade 2. Sera used with a wavelength of 660nm, power 100mW and lluencia of 8 J / cm².
  • Experimental: mucositis grade 3, laser 790
    • Group 3 included patients with oral mucositis grade 3 Sera used laser diode AsGaAl operating in continuous mode, with a wavelength of 790 nm, power of 100mW and fluency of 8 J / cm².

Clinical Trial Outcome Measures

Primary Measures

  • Oral mucositis WHO classification
    • Time Frame: During the first two week evaluation
    • The assessment of oral mucositis will be held with the WHO classification: grade 0 = no mucositis; Grade I = erythema without injury; Grade II = ulcers, but can eat; Grade III = painful sores, but able to consume liquid food (nutrition), with support of analgesia; Grade IV = requires parenteral or enteral support and continuous analgesia.

Secondary Measures

  • Visual analog scale
    • Time Frame: A week before and week after the laser application
    • The patient also conduct a self-assessment of pain by visual analog scale pain quantifying 0-10 before the laser section and after the first application.

Participating in This Clinical Trial

Inclusion Criteria

  • Pediatric male or female, diagnosed with cancer who have not yet started cancer treatment, with otherwise healthy oral mucosa in the initial dental exam. Exclusion Criteria:

  • Patients who have already started treatment for cancer under radiotherapy or presenting traumatic factors (such as braces or restorations with sharp edges), or presenting ulcers in the mucosa at the initial examination.

Gender Eligibility: All

Minimum Age: 1 Year

Maximum Age: 25 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Universidade Federal do Rio Grande do Norte
  • Provider of Information About this Clinical Study
    • Principal Investigator: Salomão Israel Monteiro Lourenço Queiroz, PhD student – Universidade Federal do Rio Grande do Norte
  • Overall Contact(s)
    • Bruno CV Gurgel, 558499894490, bcgurgel@yahoo.com.br

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