Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00036712
Status:
UNKNOWN
Last Update Posted:
2013-09-20
First Post:
2002-05-13
Brief Title:
Light-Emitting Diode Therapy in Preventing Mucositis in Children Receiving Chemotherapy With or Without Radiation Therapy Before Bone Marrow Transplantation
Sponsor:
Medical College of Wisconsin
Organization:
National Cancer Institute NCI
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2009-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-V02-1699 | None | None | None |
| MCW-HRRC-28600 | None | None | None |
| MCW-CHW-0070 | None | None | None |