1. Amelioration of Oral Mucositis Pain by NASA Near Infra Red Light Emitting Diodes in Bone Marrow Transplant Patients Hodgson BD 1,2, Margolis DM 2, Williams LD 3, Salzman DE 3, Sande JE 3,4, Vaughan WP 3, Whelan HT 2 1 Marquette University School of Dentistry, 2 Medical College of Wisconsin 3 University of Alabama, Birmingham, 4 The Children’s Hospital of Alabama Purpose To investigate the use of extra-orally applied near infra-red (NIR) phototherapy for the reduction of oral pain secondary to cancer therapy induced mucositis in hematopoietic stem cell transplant (HSCT) patients. Methods 85 patients were recruited and dichotomized into either a regular mucositis risk group or a low mucositis risk group based on their diagnosis and treatment regimen. They were then randomly assigned to experimental phototherapy regimen group (670 (+/- 10) nm gallium-aluminum-arsenide light emitting diode (LED) device, 80 sec, ~50mW/cm 2, 4J/cm 2 ) or a placebo phototherapy group. The final patient groupings used for comparison consisted of experimental-regular risk (ER), experimental-low risk (EL), placebo-regular risk (PR), and placebo-low risk (PL). (Figure 1) Patients received the experimental or placebo light therapy from blinded providers once per day starting on the Day 0 and continued through Day +14 resulting in 7 scores per patient. Blinded evaluators examined the patients 3 times per week (M, W, F) and scored their oral tissues and patient-reported pain assessments at each evaluation utilizing the World Health Organization (WHO) mucositis scale, the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) scale, the Oral Mucositis Assessment Scale (OMAS) and pediatric and adult visual analog scales Results An exact Mantel-Haenszel Chi-square test was used to compare ordered WHO pain scale differences. Among all patients, there is a significant difference between High/Low risk groups. (p=0.0226), with the low risk groups exhibiting less pain than the high risk groups. Within the low risk patients (EL vs. PL), there is no significant treatment difference. (p=1.0). Within the high risk patients (ER vs. PR), there is a significant treatment difference. (p=0.0422) with the experimental phototherapy group exhibiting less pain than the placebo group. (Figure 2) There were no significant differences between the four groups for all of the other measurements recorded (p > 0.05) Conclusions The extra-oral application of LED phototherapy in this study was shown to have a statistically significant reduction in pain as reported by the WHO Pain Assessment scale for oral mucositis, but not for other mucositis scoring scales such as the NCI and OMAS scales. Much further research is needed through controlled trials to establish the appropriate timing, power, and energy of the phototherapy to determine the optimum therapeutic parameters. Acknowledgments This work was supported by the National Aeronautics and Space Administration Grant # NNM05AB48C; the Bleser Foundation Endowed Professorship,and the Chad Baumann Neurology Research Endowment at the Medical College of Wisconsin, Milwaukee, Wisconsin. Background Cancer therapy related oral mucositis is a common side effect of chemo and radiation therapy. Oral mucositis involves inflammation and ulceration of the oral and gastrointestinal mucosa. The degree of ulceration and pain is often a limiting factor in cancer therapy. Figure 1: Diagram of patient assignment. Figure 2: Graph of differences in WHO Pain scores by observation point. (EL - experimental – low risk group; ER - experimental - regular risk group; PL – placebo – low risk group; PR – placebo – regular risk group) Table 2: Listing of Diagnoses and Treatment regimens. Table 1: Age distribution of treatment groups. Key Word # 08-066 Abstract # 222 Presented at Multinational Association of Supportive Care in Cancer Annual Meeting, Vancouver, BC June 2010