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

NCT ID: NCT02020928

Last Updated: 2013-12-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2015-08-31

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.

Conditions

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

Keywords

Oral Mucositis; chemotherapy; Bone Marrow Transplantation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Low level laser therapy

Intervention Type: DEVICE

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

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

Group Type: SHAM_COMPARATOR

Low level laser therapy

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto Materno Infantil Prof. Fernando Figueira

OTHER

Sponsor Role: lead

Responsible Party

Flavia orange

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Flavia A de Orange, PhD

Role: STUDY_DIRECTOR

Instituto de Medicina Integral Prof Fernando Figueira -Brazil

Locations

Instituto de Medicina Integral Prof. Fernando Figueira

Recife, Pernambuco, Brazil

Countries

Brazil

References

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.

Reference Type: BACKGROUND

PMID: 20969443 (View on PubMed)

Other Identifiers

3547-13

Identifier Type: -

Identifier Source: org_study_id