Oral Mucositis and Laser Therapy Associated With Photodynamic Therapy (OMLTPT)

September 18, 2015 updated by: Meire Coelho Ferreira, Universidade Ceuma

Laser Therapy Associated With Photodynamic Therapy in the Treatment of Oral Mucositis Induced by Chemotherapy in Young Patients: Randomized Blind Clinical Trial

The aim of the study was to evaluate the therapeutic action through the diameter of the lesion, of low level laser (LLL) associated to photodynamic therapy (PDT) in oral mucositis (OM) lesions, in young patients. A randomized clinical trial blinded, split-mouth was performed. The study sample consisted of 15 cancer patients (3-16 years old) of Aldenora Bello Hospital (São Luís, Maranhão, Brazil). Random allocation by lot of treatments (PDT + LLL and LLL) to quadrants of the oral cavity was performed, and the patient was his own control. Patients were masked about therapy performed on each side of the arch. The evaluation period of both therapeutic regimens was 8 days, and the outcome assessed was the lesion size (measured in cm²). Friedman and Wilcoxon tests were applied and the effect magnitude calculated. The significance level was 5%. Statistically significant difference was observed between the groups for the lesion diameter of the 6th to the 8th day (greater regression of lesion size for the PDT + LLL group), which was confirmed by a difference magnitude moderated. Based on the findings, it is concluded that PDT + LLL showed greater therapeutic effect when compared to LLL in reducing the severity of OM lesions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The blind randomized clinical trial included 18 young patients, between 3 and 16 years old, undergoing chemotherapy or chemo/radiological the pediatric ward of Aldenora Bello Hospital in São Luís (Maranhão, Brazil). The study was conducted from October/2014 to January/2015. It was adopted as inclusion criteria patients between 3 and 18 years old, in the inductive phase of chemotherapy, with oral mucositis (OM) and bilateral lesions.

A mouth split model was conducted, and the patients were their own controls. The entry of the patients in the study occurred consecutively. To each patient, the operator/examiner drafted an envelope containing treatments to either side, being masked patient about the treatment of each side: PDT (photosensitized and low level laser) + low level laser; Low level laser].

The following parameters were used for the calculation of sample size: 95% confidence level, 80% statistical power and minimal difference of 0.82 point in the lesions diameter detected between paired samples. A "n" sample minimum of 14 was determined for each treatment. In order to compensate for possible losses, 18 patients were treated.

The treatments (PDT and low level laser; Low level laser) were performed in a hospital bed. Prior to treatment, the OM lesions were evaluated and a lesion on each side was chosen. Lesions should be located at the same site on both sides. The chosen site was the lip mucosa. Before the procedure, the patient was instructed as to brushing and not using mouthwashes, followed by cleaning of the oral cavity with gauze and distilled water. Two days before the laser treatment, the side of the oral cavity chosen for the experimental treatment (PDT and low level laser) was pigmented with the photosensitizer (aqueous solution of 0.005% methylene blue). A ball of sterile cotton was soaked in the dye solution and placed in the center of the lesion. Photosensitizer remained in the place for 5 minutes (pre-irradiation period). Then, to activate the dye, the lesion was irradiated with red light (InGaAlP / phosphide and Indium, Gallium and potassium) (Flash Laser III, DMC, São Carlos, São Paulo, Brazil), with a wavelength of 660 nm, for a period 90 seconds, with a power of 100mW, to 1cm away, according to the manufacturer's specifications. The lesion on the opposite side was treated with ball of sterile cotton soaked in distilled water and the laser unit placed on the lesion without activation of the light. This procedure aimed to mask the patient about the side that received the experimental therapy (PDT and low level laser). This masking was possible because the experimental solution is insipid, very soluble and thus leaves no residue.

From the 3rd to the 10th day (total of 8 days) was carried out only laser therapy on both sides. Lesions were evaluated until the 8th day. After the 8th day of assessment, the lesions were only treated to a complete remission as well as other lesions present in the oral cavity. For laser therapy was first used infrared emitter laser unit with active medium AsGaAl (Gallium Arsenide and Aluminium), with wavelength of 808nm, for analgesia. Then, the investigators used the red emitter, whose active medium was the InGaAlP (phosphide and Indium, Gallium and Potassium), with wavelength of 660nm to photobiomodulation. For both units emitting laser, the tip of the device was closed against the edges of the lesion, perpendicular to the tissue. A irradiation was continuous and the application punctual (10 seconds). The distance between the points of irradiation was about 1cm. The energy delivered was 4J per point of application. The interval between sessions was 24 hours.

The tip of the laser was disinfected with 70% alcohol solution and wrapped with a plastic film. Patients and operators wore glasses for eye protection.

A questionnaire containing demographic, socioeconomic and type of treatment for cancer was applied to parents and children. White blood cell count and platelets (beginning and end of the inductive phase of QT) were extracted from medical records.

The assessed outcome measure was the diameter of the lesion (in cm2). The areas of the lesions were measured with a flexible ruler (record made in cm2) by the operator/examiner from the start of treatment with exclusive laser therapy (3rd day). This procedure was repeated on subsequent days until the 8th day of laser treatment. The measurement of the lesions occurred prior to laser therapy applications.

The Friedman test was used for multiple comparisons within groups (different times of treatment). Paired evaluation between each two moments was evaluated using the Wilcoxon test, with significance corrected by Bonferroni test (p = 0.0071). The Wilcoxon test was used to compare the diameter of the lesion, every day, between the PDT + Low level laser and Low level laser groups (dependent samples/split-mouth). It calculated the effect magnitude (d) of standardized differences between averages of two groups. The level of significance for analysis was 5%.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Maranhão
      • São Luís, Maranhão, Brazil, 65031-630
        • Hospital Aldenora Bello

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients between 3 and 18 years old
  • Patients on chemotherapy inductive phase
  • Patients with oral mucositis and bilateral lesions

Exclusion Criteria:

  • Patients outside the established age
  • Patients who are in other phases of chemotherapy
  • Patients who did not have bilateral lesions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PDT + Low level laser

PDT (photosensitizer and low level laser) and low level laser

Photosensitizer: aqueous solution of 0.005% methylene blue; Low level laser: infrared emitter laser unit with active medium AsGaAl (Gallium Arsenide and Aluminium) and red emitter with active medium InGaAlP (phosphide and Indium, Gallium and Potassium)
Other: PDT + Low level laser

Two days before the laser treatment, the side of the oral cavity chosen for the experimental treatment was pigmented with aqueous solution of 0.005% methylene blue. A ball of sterile cotton was soaked in the dye solution and placed in the center of the lesion. Photosensitizer remained in the place for 5 minutes (pre-irradiation period). Then, to activate the dye, the lesion was irradiated with red light (InGaAlP / phosphide and Indium, Gallium and potassium).

From the 3rd to the 10th day was carried out only laser therapy. For laser therapy was first used infrared emitter laser unit with active medium AsGaAl (Gallium Arsenide and Aluminium). Then, we used the red emitter, whose active medium was the InGaAlP (phosphide and Indium, Gallium and Potassium).
Active Comparator: Low level laser
Low level laser: infrared emitter laser unit with active medium AsGaAl (Gallium Arsenide and Aluminium) and red emitter with active medium InGaAlP (phosphide and Indium, Gallium and Potassium)
Radiation: Low level laser
Two days before the laser treatment, the lesion of the side of the oral cavity chosen for the control treatment was treated with ball of sterile cotton soaked in distilled water and the laser unit placed on the lesion without activation of the light. From the 3rd to the 10th day was carried out laser therapy. For laser therapy was first used infrared emitter laser unit with active medium AsGaAl (Gallium Arsenide and Aluminium). Then, we used the red emitter, whose active medium was the InGaAlP (phosphide and Indium, Gallium and Potassium).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lesion size
Time Frame: 8 days
Lesion size measured in cm²
8 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Ceuma

Collaborators

Fundação de Amparo à Pesquisa e Desenvolvimento Científico do Maranhão

Investigators

  • Study Director: Meire C. Ferreira, PhD, Programa de Mestrado em Odontologia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

September 17, 2015

First Submitted That Met QC Criteria

September 18, 2015

First Posted (Estimate)

September 21, 2015

Study Record Updates

Last Update Posted (Estimate)

September 21, 2015

Last Update Submitted That Met QC Criteria

September 18, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCCF-060264-AM

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Oral Mucositis

Clinical Trials on PDT + Low level laser

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cameroon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe