A Multiinstitutional Trial To Evaluate The Prophylactic Use Of NASA-Developed Light Emitting Diodes For The Prevention Of Oral Mucositis In Bone Marrow Transplant Patients
- Compare the incidence and severity of oral mucositis in children undergoing
NASA-developed light-emitting diode (LED) therapy during a pre-transplantation
myeloablative conditioning regimen (chemotherapy with or without radiotherapy) and
continuing through the post-bone marrow transplantation (BMT) phase versus LED therapy
during the post-BMT phase only.
OUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified
according to participating center and cheek being treated (right vs left). Patients are
randomized to 1 of 2 schedules of light-emitting diode (LED) therapy.
- Arm I: Patients undergo LED therapy for 71 seconds once daily beginning on day 1 of the
myeloablative conditioning regimen comprising chemotherapy with or without radiotherapy
and continuing for 14 days after bone marrow transplantation (BMT).
- Arm II: Patients undergo LED therapy as in arm I beginning on the day of BMT (day 0)
and continuing for 14 days after BMT.
Photographs are taken of the right and left buccal mucosa at baseline and then every 3 days
beginning on day 1 of LED therapy.
Pain and xerostomia are assessed using the Wong-Baker "smiley-face" pain scale at baseline
and then periodically for 14 days after BMT.
Patients are followed monthly for 2 years.
PROJECTED ACCRUAL: A total of 80 patients (40 per arm) will be accrued for this study within
Primary Purpose: Supportive Care
Mean change in oral mucositis index (OMI) score from baseline to maximum score within 14 days posttransplant
Harry T. Whelan, MD
Medical College of Wisconsin
|Medical College of Wisconsin Cancer Center||Milwaukee, Wisconsin 53226|