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

Primary Purpose

Oral Mucositis, Effects of Chemotherapy, Malignant Neoplasm of Bone Marrow

Status
Unknown status
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Low level laser therapy
Sponsored by
Instituto Materno Infantil Prof. Fernando Figueira
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Oral Mucositis focused on measuring Oral Mucositis, chemotherapy, Bone Marrow Transplantation

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Instituto de Medicina Integral Prof. Fernando Figueira

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Low level laser therapy

sham

Arm Description

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.

patients will receive sham Low level laser therapy - the device is triggered, but not deliver the laser light

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Degree of mucositis
From the first day after the transplantation to the eighth day after transplantation

Full Information

First Posted
December 19, 2013
Last Updated
December 19, 2013
Sponsor
Instituto Materno Infantil Prof. Fernando Figueira
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1. Study Identification

Unique Protocol Identification Number
NCT02020928
Brief Title
Laser Therapy Prevents Mucositis Oral in Chemotherapy for Bone Marrow Transplantation?
Acronym
lasertherapy
Official Title
Laser Therapy Prevents Mucositis Oral in Patients Undergoing to Chemotherapy for Bone Marrow Transplantation? A Randomized Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
July 2015 (Anticipated)
Study Completion Date
August 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Materno Infantil Prof. Fernando Figueira

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Mucositis, Effects of Chemotherapy, Malignant Neoplasm of Bone Marrow
Keywords
Oral Mucositis, chemotherapy, Bone Marrow Transplantation

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low level laser therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
sham
Arm Type
Sham Comparator
Arm Description
patients will receive sham Low level laser therapy - the device is triggered, but not deliver the laser light
Intervention Type
Device
Intervention Name(s)
Low level laser therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of Oral Mucositis
Description
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
Secondary Outcome Measure Information:
Title
Degree of mucositis
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Flavia A de Orange, PhD
Organizational Affiliation
Instituto de Medicina Integral Prof Fernando Figueira -Brazil
Official's Role
Study Director
Facility Information:
Facility Name
Instituto de Medicina Integral Prof. Fernando Figueira
City
Recife
State/Province
Pernambuco
ZIP/Postal Code
50070-550
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
20969443
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.
Results Reference
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Laser Therapy Prevents Mucositis Oral in Chemotherapy for Bone Marrow Transplantation?

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