Oral Mucositis Clinical Trial
Official title:
Laser Therapy Prevents Mucositis Oral in Patients Undergoing to Chemotherapy for Bone Marrow Transplantation? A Randomized Clinical Trial.
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
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