Light-Emitting Diode Therapy in Preventing Mucositis in Children Receiving Chemotherapy With or Without Radiation Therapy Before Bone Marrow Transplantation
Recruitment status was: Recruiting
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.
|Chronic Myeloproliferative Disorders Kidney Cancer Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Neoplasms Neuroblastoma Oral Complications Ovarian Cancer Pain Sarcoma||Procedure: management of therapy complications Procedure: pain therapy||Phase 2|
|Study Design:||Primary Purpose: Supportive Care|
|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|
- Mean change in oral mucositis index (OMI) score from baseline to maximum score within 14 days posttransplant
- Mean change in pain score from baseline to maximum score within 14 days posttransplant
- Proportion of patients not experiencing ulcerative mucositis within the first 14 days posttransplant
- Time to heal
|Study Start Date:||January 2002|
|Estimated Primary Completion Date:||August 2009 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00036712
|United States, Wisconsin|
|Medical College of Wisconsin Cancer Center||Recruiting|
|Milwaukee, Wisconsin, United States, 53226|
|Contact: Clinical Trials Office - Medical College of Wisconsin Cancer C 414-805-4380|
|Study Chair:||Harry T. Whelan, MD||Medical College of Wisconsin|