Light-Emitting Diode Therapy in Preventing Mucositis in Children Receiving Chemotherapy With or Without Radiation Therapy Before Bone Marrow Transplantation
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
Sponsor: Medical College of Wisconsin
A PHASE2 clinical study on Chronic Myeloproliferative Disorders and Kidney Cancer, this trial is ongoing. The trial is conducted by Medical College of Wisconsin and has accumulated 5 data snapshots since 2002. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.
Study Description(click to expand)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...
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.
Status Flow
Change History
5 versions recorded-
Sep 2024 — Present [monthly]
Unknown PHASE2
-
Jul 2024 — Sep 2024 [monthly]
Unknown PHASE2
Status: Unknown Status → Unknown
-
Jan 2021 — Jul 2024 [monthly]
Unknown Status PHASE2
-
Jun 2018 — Jan 2021 [monthly]
Unknown Status PHASE2
-
Jan 2017 — Jun 2018 [monthly]
Unknown Status PHASE2
First recorded
Jan 2002
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Medical College of Wisconsin
For direct contact, visit the study record on ClinicalTrials.gov .