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

Oral Mucositis Clinical Trial

— lasertherapy  

Official title:

Laser Therapy Prevents Mucositis Oral in Patients Undergoing to Chemotherapy for Bone Marrow Transplantation? A Randomized Clinical Trial.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02020928
• Other study ID #: 3547-13
• Status: Enrolling by invitation
• Phase: Phase 3
• First received: December 19, 2013
• Last updated: December 19, 2013
• Start date: January 2015
• Est. completion date: August 2015

Study information

• Verified date: September 2013
• Source: Instituto Materno Infantil Prof. Fernando Figueira
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 36
• Est. completion date: August 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bone Marrow Neoplasms
• Bone Neoplasms
• Effects of Chemotherapy
• Malignant Neoplasm of Bone Marrow
• Mucositis
• Neoplasms
• Oral Mucositis
• Stomatitis

Intervention

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.

Locations

Country	Name	City	State
Brazil	Instituto de Medicina Integral Prof. Fernando Figueira	Recife	Pernambuco

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Materno Infantil Prof. Fernando Figueira

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

Silva GB, Mendonça 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Oral Mucositis	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	Yes
Secondary	Degree of mucositis	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	Yes