Oral Mucositis
A Randomized Placebo-Controlled Clinical Trial of Low Level Laser Therapy for Prevention of Oral Mucositis in Children and Adolescents Undergoing a Hematopoietic Stem Cell Transplant
Researcher: Belinda Mandrell, PhD RN
Co-Investigators: Chris Rowland, DDS; Brandon Triplett MD
Institution: St. Jude Children’s Research Hospital | Memphis, Tennessee
Grant Type: APHON/CureSearch Dr. Rachel Booth Award in Nursing Research
Year Awarded: 2016
Abstract
Oral mucositis is a significant and common toxicity experienced by patients who receive high-dose chemotherapy as a preparatory regimen for a hematopoietic stem cell transplant (HSCT).The use of Low Laser Light Therapy (LLLT) in adult patients is well documented and now included in mucositis guidelines , with evidence limited in pediatrics. The purpose of this study is to determine if low-laser light therapy compared to sham can reduce the severity and duration of HSCT chemotherapy induced oral mucositis. This controlled clinical trial will randomize children (≥ 7 years) and adolescents to LLLT (wavelength at 650 nm, power of 40 mW, and each square centimeter treated with the required time to a tissue energy dose of 2 J/cm2) or sham. The laser treatment will be administered via the FDA approved THOR laser. All patients will receive mouth care per standard of care. Outcome assessments include patient reported pain and rating of mucositis and duration using the CTCAE v.4 will be completed by the nurse and nurse practitioner. The study nurse will also review and document the use of analgesia for each patient. A sample size of 25 participants to each arm will be required to achieve 80% power to detect a 0.09 standard deviation unit difference between the treatment group and control at the 0.05 significance level. This intervention has potential in providing prevention and treatment for the single most debilitating side effect as reported by patients undergoing HSCT. If the laser therapy is found to reduce mucositis severity and duration, laser therapy should be incorporated into daily nursing care for patients undergoing HSCT thus improving patient outcomes.