Milwaukee, Wisconsin 53226


Purpose:

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.


Study summary:

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.


Criteria:

DISEASE CHARACTERISTICS: - Patients undergoing a myeloablative conditioning regimen comprising chemotherapy with or without radiotherapy prior to a first allogeneic bone marrow transplantation PATIENT CHARACTERISTICS: Age: - 2 to 18 Performance status: - Not specified Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - Not specified Renal: - Not specified Pulmonary: - No pulmonary dysfunction that would increase significantly the risk of requiring intubation during the first 21 days after transplantation Other: - Not pregnant - Negative pregnancy test - Fertile patients must use effective contraception - No photophobia - Must have emotional, cognitive, and mental maturity sufficient to tolerate light-emitting diode therapy application and oral examination without combativeness PRIOR CONCURRENT THERAPY: Biologic therapy: - See Disease Characteristics Chemotherapy: - See Disease Characteristics Endocrine therapy: - Not specified Radiotherapy: - See Disease Characteristics Surgery: - Not specified Other: - No concurrent medication that may cause epidermal or ocular photosensitivity


NCT ID:

NCT00036712


Primary Contact:

Study Chair
Harry T. Whelan, MD
Medical College of Wisconsin


Backup Contact:

N/A


Location Contact:

Milwaukee, Wisconsin 53226
United States

Clinical Trials Office - Medical College of Wisconsin Cancer C
Phone: 414-805-4380

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: December 12, 2017

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