A Phase 3 interventional study of Low level laser therapy in Oral Mucositis, Effects of Chemotherapy and Malignant Neoplasm of Bone Marrow, sponsored by Instituto Materno Infantil Prof. Fernando Figueira. Status unknown at 1 site in Brazil. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2013-12-25.
Sponsored by Instituto Materno Infantil Prof. Fernando Figueira · Phase 3, Interventional, and Prevention
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.
408 studies on the registry are indexed under Stomatitis; 85 are open to participants now.
This study's planned enrollment of 36 is below the median of 60 across 356 interventional studies indexed under Stomatitis.
Browse Stomatitis studies →Instituto Materno Infantil Prof. Fernando Figueira is the lead sponsor of 32 studies on the registry; 2 are open to participants now.
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BMT;
Exclusion Criteria:
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.
Device: Low level laser therapy
patients will receive sham Low level laser therapy - the device is triggered, but not deliver the laser light
Device: Low level laser therapy
Low level laser therapy: Laser Therapy XT (DMC) having red light with a wave length of 660 nm (± 10 nm) and infrared light with a wavelength of 808 nm (± 10 nm) is used, both power of 100 mW (± 20%), applied in a timely manner.
Incidence of Oral Mucositis
From the first day after the transplantation to the eighth day after transplantation
Time frame: From the first day after the transplantation to the eighth day after transplantation
Degree of mucositis
From the first day after the transplantation to the eighth day after transplantation
Time frame: From the first day after the transplantation to the eighth day after transplantation
This study is status unknown, as verified in Sep 2013. You cannot join it, but the record below documents what was studied.
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Instituto Materno Infantil Prof. Fernando Figueira