Low-level Laser Therapy on Inflammatory Mediators During Chemotherapy-induced Oral Mucositis

NCT02050373 | Completed Results DMC

• 1 other identifier: 382/2011
• Study Type: interventional
• Target: 51
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of the study is to evaluate the effect of low-level laser therapy (LLLT) on the severity of oral mucositis (OM) and inflammatory mediators (pro- and anti-inflammatory cytokines, metalloproteinases and growth factors) levels in saliva and blood; furthermore, analyze the effect of LLLT in product modulation of oxidative stress and cell damage from the oral mucosa transplant patients.

Conditions

Oral Mucositis

Keywords

Mucositis; inflammation; Chemotherapy; Hematopoietic stem cell transplant; Low level laser therapy; oxidative stress

Outcome Measures

Primary Outcomes (1)

• Severity of Oral Mucositis

  A trained clinical member of the team who was blind to the randomization allocation scores the degree of OM, during the hospitalization, in accordance to the World Health Organization (WHO) mucositis scale as follow: grade 0, no signs or symptoms; grade 1, painless ulcers, erythema, or mild soreness; grade 2, painful erythema, edema, or ulceration but the patient is able to eat; grade 3, mucosal damage and the patient is able to ingest only liquids; and grade 4, severe mucosa damage and the patient requires parenteral or enteral support.

  On day of the transplant (D0), on seventh day after the transplant (D7) and discharge of the patient (HD) or until day 20 (D+20).

Secondary Outcomes (1)

• Level of Inflammatory Mediators

  The samples were collected at three different moments of treatment: at the time of admission (AD), on the seventh day after transplantation (D+7), and on the day of discharge (with neutrophil >0.5 × 109/l for two consecutive days) (HD).

Study Arms (2)

Low-Level laser

EXPERIMENTAL

In the laser group, an indium phosphide, galium and aluminum (InGaAIP) diode laser (660nm, 40mW, 0.16 J, 4 J/cm2) was used to irradiate oral mucosa. Subjects received the LLLT from the first day of the conditioning regimen and continued until D+7. Laser therapy was applied by a single dentist expertise in laser irradiation. The tip touched the mucosa of the lips, right and left buccal mucosa, right and left lateral tongue, ventral tongue and buccal floor, giving a total of 10 points per region.

Radiation: Low-Level laser

Control

NO INTERVENTION

In the control group, patients receive only the preventive protocol bone marrow transplant industry, consisting of mouthwashes and sodium fluoride. For ethical reasons, individuals who present oral mucositis grade 2 (WHO) will receive LLLT.

Interventions

Low-Level laser RADIATION

Application of laser therapy in low power mucosa jugal right and left upper and lower labial mucosa, floor of the mouth, tongue side of the right and left and belly of the tongue.

Low-Level laser

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Schedule to receive myeloablative conditioning regimens using chemotherapy; oral mucosa lining intact on the first day of the conditioning regimen;

You may not qualify if:

• Patients who presented with oral oral ulceration or erosion, active oral, viral, bacterial, or fungal infections on admission, or active oral bleeding which was uncontrollable during laser therapy or had required oral tracheal intubation during hospitalization in the HSCT Unit.

Sponsors & Collaborators

• Universidade Federal de Goias: lead
• Federal University of Minas Gerais: collaborator
• Araujo Jorge Hospital: collaborator

MeSH Terms

Conditions

Stomatitis; Mucositis; Inflammation

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Limitations and Caveats

The clinical trials with cancer patients submitted to HSCT include difficulty in homogenizing the underlying disease and treatment protocols and the influence of the underlying disease on the blood or salivary levels of chemical mediators.

Results Point of Contact

• Title: Daniella Salvador
• Organization: UFGoias

danirnsalvador@gmail.com

556235583272

Study Officials

• Geisa BL Silva, Master

  Universidade Federal de Goias

  PRINCIPAL INVESTIGATOR

• Aline C Batista, Doctor

  Universidade Federal de Goias

  STUDY DIRECTOR

• Daniella RN Salvador

  Universidade Federal de Goias

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: January 26, 2014
• First Posted: January 30, 2014
• Study Start: January 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: February 1, 2017
• Last Updated: January 22, 2021
• Results First Posted: January 22, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share