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

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ClinicalTrials.gov Identifier: NCT02020928
Recruitment Status : Unknown
Verified September 2013 by Flavia orange, Instituto Materno Infantil Prof. Fernando Figueira.
Recruitment status was:  Enrolling by invitation
First Posted : December 25, 2013
Last Update Posted : December 25, 2013
Sponsor:
Information provided by (Responsible Party):
Flavia orange, Instituto Materno Infantil Prof. Fernando Figueira

Study Description
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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.


Condition or disease Intervention/treatment Phase
Oral Mucositis Effects of Chemotherapy Malignant Neoplasm of Bone Marrow Device: Low level laser therapy Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Laser Therapy Prevents Mucositis Oral in Patients Undergoing to Chemotherapy for Bone Marrow Transplantation? A Randomized Clinical Trial.
Study Start Date : January 2015
Estimated Primary Completion Date : July 2015
Estimated Study Completion Date : August 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 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.
Sham Comparator: sham
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.


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of Oral Mucositis [ Time Frame: 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 :
  1. Degree of mucositis [ Time Frame: 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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02020928


Locations
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Brazil
Instituto de Medicina Integral Prof. Fernando Figueira
Recife, Pernambuco, Brazil, 50070-550
Sponsors and Collaborators
Instituto Materno Infantil Prof. Fernando Figueira
Investigators
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Study Director: Flavia A de Orange, PhD Instituto de Medicina Integral Prof Fernando Figueira -Brazil
More Information
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Publications:

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Responsible Party: Flavia orange, MD, PhD, Instituto Materno Infantil Prof. Fernando Figueira
ClinicalTrials.gov Identifier: NCT02020928    
Other Study ID Numbers: 3547-13
First Posted: December 25, 2013    Key Record Dates
Last Update Posted: December 25, 2013
Last Verified: September 2013
Keywords provided by Flavia orange, Instituto Materno Infantil Prof. Fernando Figueira:
Oral Mucositis
chemotherapy
Bone Marrow Transplantation
Additional relevant MeSH terms:
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Neoplasms
Bone Neoplasms
Bone Marrow Neoplasms
Mucositis
Stomatitis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
 Mouth Diseases
Stomatognathic Diseases
Neoplasms by Site
Bone Diseases
Musculoskeletal Diseases
Hematologic Neoplasms
Bone Marrow Diseases
Hematologic Diseases