Pain Clinical Trial
Official title:
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
RATIONALE: Light-emitting diode (LED) therapy may be able to prevent mucositis of the mouth.
PURPOSE: Randomized phase II trial to determine the effectiveness of LED therapy in
preventing mucositis of the mouth in children who are receiving chemotherapy with or without
radiation therapy before donor bone marrow transplantation.
OBJECTIVES:
- 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
2 years.
;
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