The Path to an Evidence-Based Treatment Protocol for Extraoral Photobiomodulation Therapy for the Prevention of Oral Mucositis.
Ather Adnan, Anna N Yaroslavsky, James D Carroll...
https://pubmed.ncbi.nlm.nih.gov/35048034Actively Recruiting
Phase 3
Age: 18Years - 100Years
All Genders
ID06071637
Low Power Laser Therapy As Prevention Of Oral Mucositis And Oropharyngeal Pain In Patients Undergoing Allogenetic Hematopoietic Stem Cell Transplantation.
Led by Instituto Nacional de Cancer, Brazil · Updated on 2023-10-06
84
Participants Needed
2
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating two different low-power laser therapy protocols to prevent oral mucositis and oropharyngeal pain in patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT). This phase III, double-blind, randomized study aims to compare the effects of applying laser light at different wavelengths either separately or simultaneously in the mouth and neck regions to reduce symptoms like pain, swallowing difficulties, and the need for total parenteral nutrition or opioid use during HSCT. The study divides participants into two groups. Group A receives separate applications of red (660 nm) and infrared (808 nm) laser light, while Group B receives simultaneous dual-wavelength application of red and infrared light. The treatment is delivered by a dental surgeon on weekdays, starting seven days before conditioning (D-7) and continuing until the bone marrow "take" (when neutrophil counts reach 500 for three consecutive days). Extraoral laser application targets the bilateral carotid triangle, and intraoral treatment covers multiple oral mucosa sites. The laser devices used have specific power and beam area settings, and safety protocols like protective eyewear and disinfection are followed. Participants are evaluated daily on weekdays for oral mucositis severity, oral and oropharyngeal pain, swallowing difficulty, and use of nutritional support or opioids during approximately 21 to 28 days of hospitalization for HSCT. Assessments include physical oral exams, pain scales, and mucositis grading using WHO and OMAS scales. Data are collected from medical records and electronic systems for analysis. The main outcomes measured are prevention of mucositis, pain, dysphagia, and need for total parenteral nutrition or opioids. The study also monitors safety and collects detailed clinical and demographic information throughout the treatment period.
CONDITIONS
Brief Title
Low Power Laser Therapy As Prevention Of Oral Mucositis And Oropharyngeal Pain In Patients Undergoing Allogenetic HSCT
Who Can Participate
Age: 18Years - 100Years
All Genders
Eligibility Criteria
You may qualify if you...
- Patients with indication for allogeneic HSCT
- Patients over 18 years old
- Patients with intact oral mucosa on the first day of conditioning (D-7)
- Patients able to cooperate with treatment
- Patients capable of performing the oral hygiene protocol
- Patients who agreed to participate in the study through the informed consent form (TCLE) in accordance with Resolution 466/12 of the National Health Council.
You will not qualify if you...
- Patients who are receiving medication for the treatment and/or prevention of mucositis
- Patients who were not previously evaluated and released by INCA's Dentistry section team
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for pre-HSCT dental evaluation including physical and radiographic examination
Treatment
Duration - Approximately 3 to 4 weeks
Participants receive low-power laser therapy starting on the first day of conditioning (D-7) until the bone marrow 'take' (approximately Day 14 to Day 21). They also follow an oral hygiene protocol during this period.
Daily visits on weekdays for laser application and oral mucositis, pain, and dysphagia assessments
Follow-up
Duration - Until resolution of oral mucositis after bone marrow take
Participants who develop oral mucositis receive therapeutic laser treatment and are followed until resolution of the condition according to hospital routine.
Visits as needed based on mucositis treatment
Trial Site Locations
Total: 2 locations
1
Instituto Nacional de Cancer
Rio de Janeiro, Rio de Janeiro, Brazil, 20231-050
Actively Recruiting
2
Instituto Nacional de Cancer
Rio de Janeiro, Brazil, 20231-050
Actively Recruiting
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Published Research Related To This Trial
Low-power laser in the prevention of induced oral mucositis in bone marrow transplantation patients: a randomized trial.
Héliton Spíndola Antunes, Alexandre Mello de Azevedo, Luiz Fernando da Silva Bouzas...
https://pubmed.ncbi.nlm.nih.gov/17053058Bone marrow transplantation.
J O Armitage
https://pubmed.ncbi.nlm.nih.gov/8114836Haematopoietic stem cell transplants: principles and indications.
Katalin Balassa, Robert Danby, Vanderson Rocha
https://pubmed.ncbi.nlm.nih.gov/30592675[Bone marrow transplantation and cord blood transplantation in children].
Cláudio Galvão de Castro, L J Gregianin, A L Brunetto
https://pubmed.ncbi.nlm.nih.gov/14647838The Incidence and Severity of Oral Mucositis among Allogeneic Hematopoietic Stem Cell Transplantation Patients: A Systematic Review.
Hafsa M Chaudhry, Alison J Bruce, Robert C Wolf...
https://pubmed.ncbi.nlm.nih.gov/26409924Hematopoietic stem-cell transplantation.
Edward A Copelan
https://pubmed.ncbi.nlm.nih.gov/16641398Photobiomodulation on the angiogenesis of skin wounds in rats using different light sources.
Adalberto Vieira Corazza, Jacks Jorge, Cristina Kurachi...
https://pubmed.ncbi.nlm.nih.gov/17508845Basic oral care for hematology-oncology patients and hematopoietic stem cell transplantation recipients: a position paper from the joint task force of the Multinational Association of Supportive Care in Cancer/International Society of Oral Oncology (MASCC/ISOO) and the European Society for Blood and Marrow Transplantation (EBMT).
Sharon Elad, Judith E Raber-Durlacher, Michael T Brennan...
https://pubmed.ncbi.nlm.nih.gov/25189149MASCC/ISOO clinical practice guidelines for the management of mucositis secondary to cancer therapy.
Sharon Elad, Karis Kin Fong Cheng, Rajesh V Lalla...
https://pubmed.ncbi.nlm.nih.gov/32786044