Light-Emitting Diode Therapy in Preventing Mucositis in Children Receiving Chemotherapy With or Without Radiation Therapy Before Bone Marrow Transplantation
The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by National Cancer Institute (NCI).
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Medical College of Wisconsin
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00036712
First received: May 13, 2002
Last updated: April 9, 2010
Last verified: June 2009
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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.
| Condition | Intervention | Phase |
|---|---|---|
|
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 Type: | Interventional |
| 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
acute promyelocytic leukemia
neuroblastoma
primary myelofibrosis
MedlinePlus related topics:
Bone Marrow Transplantation
Cancer
Chronic Lymphocytic Leukemia
Chronic Myeloid Leukemia
Kidney Cancer
Leukemia
Lymphoma
Multiple Myeloma
Myelodysplastic Syndromes
Neuroblastoma
Ovarian Cancer
Soft Tissue Sarcoma
U.S. FDA Resources
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- 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
Secondary Outcome Measures:
- Time to heal
| Estimated Enrollment: | 80 |
| Study Start Date: | January 2002 |
| Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 2 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00036712
Locations
| 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 | |
Sponsors and Collaborators
Medical College of Wisconsin
Investigators
| Study Chair: | Harry T. Whelan, MD | Medical College of Wisconsin |
More Information
Additional Information:
No publications provided
| Responsible Party: | Harry T. Whelan, Medical College of Wisconsin Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00036712 History of Changes |
| Other Study ID Numbers: | CDR0000069293, MCW-HRRC-28600, MCW-CHW-0070, NCI-V02-1699 |
| Study First Received: | May 13, 2002 |
| Last Updated: | April 9, 2010 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
recurrent childhood acute lymphoblastic leukemia refractory multiple myeloma recurrent childhood rhabdomyosarcoma disseminated neuroblastoma recurrent neuroblastoma recurrent Wilms tumor and other childhood kidney tumors recurrent childhood lymphoblastic lymphoma stage III chronic lymphocytic leukemia stage IV chronic lymphocytic leukemia recurrent childhood acute myeloid leukemia relapsing chronic myelogenous leukemia refractory chronic lymphocytic leukemia chronic phase chronic myelogenous leukemia accelerated phase chronic myelogenous leukemia blastic phase chronic myelogenous leukemia |
primary myelofibrosis childhood acute promyelocytic leukemia (M3) refractory hairy cell leukemia oral complications recurrent/refractory childhood Hodgkin lymphoma de novo myelodysplastic syndromes previously treated myelodysplastic syndromes secondary myelodysplastic syndromes pain recurrent childhood small noncleaved cell lymphoma recurrent childhood large cell lymphoma previously treated childhood rhabdomyosarcoma childhood malignant ovarian germ cell tumor childhood chronic myelogenous leukemia atypical chronic myeloid leukemia, BCR-ABL negative |
Additional relevant MeSH terms:
|
Neoplasms Carcinoma, Renal Cell Kidney Neoplasms Leukemia Lymphoma Multiple Myeloma Neoplasms, Plasma Cell Plasmacytoma Myelodysplastic Syndromes Preleukemia Myeloproliferative Disorders Neuroblastoma Ovarian Neoplasms Mucositis Sarcoma |
Myelodysplastic-Myeloproliferative Diseases Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Kidney Diseases Urologic Diseases Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Hemostatic Disorders |
ClinicalTrials.gov processed this record on May 19, 2013