Clinical trial NCT02020928: Laser Therapy Prevents Mucositis Oral in Chemotherapy for Bone Marrow Transplantation?
Official title: Laser Therapy Prevents Mucositis Oral in Patients Undergoing to Chemotherapy for Bone Marrow Transplantation? A Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Oral Mucositis
Effects of Chemotherapy
Malignant Neoplasm of Bone Marrow
Keywords: Oral Mucositis
chemotherapy
Bone Marrow Transplantation
Lead sponsor: Instituto Materno Infantil Prof. Fernando Figueira
Sponsor class: OTHER
First posted: 2013-12-25
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of Oral Mucositis
timeFrame: From the first day after the transplantation to the eighth day after transplantation
Secondary outcomes:
measure: Degree of mucositis
timeFrame: From the first day after the transplantation to the eighth day after transplantation
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Instituto de Medicina Integral Prof. Fernando Figueira
state: Pernambuco
Study officials:
affiliation: Instituto de Medicina Integral Prof Fernando Figueira -Brazil
name: Flavia A de Orange, PhD
role: STUDY_DIRECTOR
References:
citation: Silva GB, Mendonca EF, Bariani C, Antunes HS, Silva MA. The prevention of induced oral mucositis with low-level laser therapy in bone marrow transplantation patients: a randomized clinical trial. Photomed Laser Surg. 2011 Jan;29(1):27-31. doi: 10.1089/pho.2009.2699. Epub 2010 Oct 22.