Laser Therapy Prevents Mucositis Oral in Chemotherapy for Bone Marrow Transplantation?

Phase 3

• Conditions: Oral Mucositis; Effects of Chemotherapy; Malignant Neoplasm of Bone Marrow
• Interventions: Device: Low level laser therapy

• Registration Number: NCT02020928
• Lead Sponsor: Instituto Materno Infantil Prof. Fernando Figueira

Brief Summary

Setting: Oral mucositis is a very common complication of cancer treatment, accounting, often at increased risk for infections and even the interruption of treatment, interfering with the prognosis of the disease. The low intensity laser therapy has been proposed as an alternative for the treatment and prevention of this side effect, with good results in terms of clinical and functional, speeding up the process of wound healing and reducing pain.

Objective: To evaluate the effectiveness of using low power laser in the prevention of oral mucositis in patients with hematological cancer, undergoing chemotherapy for bone marrow transplantation.

Methods: There will be a Clinical Trial Randomized, double-blind study to evaluate the effectiveness of using low power laser in the prevention of oral mucositis in patients with hematological cancer, undergoing chemotherapy for bone marrow transplantation. Participate in the study, patients who are in the condition mentioned above accepting participate and have aged over 18. Will be excluded from the study patients who have autoimmune disease, which present sensitivity to laser or who have already started treatment for oral mucositis prior to this study.The study variables are:-independent variable: whether or not the red laser of low power-dependent variables: oral mucositis, degree of mucositis, chemotherapy regimen, type of blood cancer. For determining the association between the independent variable and the dependent will be used chi-square tests of association (Pearson) and Fisher's exact test, if necessary. Will calculate the risk ratio (RR) as a measure of relative risk, with the confidence interval at 95% (IC95%).Also be calculated NNT (number needed to treat to obtain benefit) and NNH (number needed to harm getting). Will be adopted a significance level of 5%. The project was approved by the Ethics and Research iMIP. All patients will be appropriately informed about the objectives of the project and will only be included if they voluntarily agree to participate by signing the consent form.

Keywords: laser, prevention and control; oral mucositis, bone marrow transplant.

Detailed Description

Inclusion Criteria: patients with blood cancers undergoing chemotherapy for

BMT; patients who agree to participate; patients older than 18 years.

Exclusion Criteria: patients with autoimmune diseases; patients who have sensitivity to the laser; patients who have already started treatment for mucositis prior to the research; HIV-positive patients.

Study Timeline

• Status Verified: 2013-09
• Study First Submitted: 2013-12-19
• Study First Submitted QC: 2013-12-19
• Last Update Submitted: 2013-12-19
• Study First Posted: 2013-12-25
• Last Update Posted: 2013-12-25
• Study Start: 2015-01
• Primary Completion: 2015-07
• Study Completion: 2015-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• patients with hematologic cancers undergoing chemotherapy for

BMT;

• patients who agree to participate;
• patients older than 18 years.

Exclusion Criteria

• patients with autoimmune diseases;
• patients who have sensitivity to the laser;
• patients who have already started treatment for mucositis prior to research.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low level laser therapy	Low level laser therapy	The Low level laser therapy application is performed from the first day of conditioning of the patient until the second day after bone marrow transplantation (D + 2). The patients are divided into two groups. The first will contain the patients who will receive the red laser light, whereas the second will cover patients who receive sham or placebo controlled - the device is triggered, but not deliver the laser light.
sham	Low level laser therapy	patients will receive sham Low level laser therapy - the device is triggered, but not deliver the laser light

Primary Outcome Measures

Name	Time	Method
Incidence of Oral Mucositis	From the first day after the transplantation to the eighth day after transplantation	From the first day after the transplantation to the eighth day after transplantation

Secondary Outcome Measures

Name	Time	Method
Degree of mucositis	From the first day after the transplantation to the eighth day after transplantation	From the first day after the transplantation to the eighth day after transplantation

Trial Locations

Locations (1)

Instituto de Medicina Integral Prof. Fernando Figueira; 🇧🇷 Recife, Pernambuco, Brazil