Comparing Two Low-Power Laser Therapy Methods to Prevent Oral Mucositis and Throat Pain in Adults Undergoing Allogeneic Hematopoietic Stem Cell Transplantation

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.

Low Power Laser Therapy As Prevention Of Oral Mucositis And Oropharyngeal Pain In Patients Undergoing Allogenetic HSCT