Light-Emitting Diode Therapy in Preventing Mucositis in Children Receiving Chemotherapy With or Without Radiation Therapy Before Bone Marrow Transplantation - Full Text View

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: neuroblastoma

MedlinePlus related topics: Bone Marrow Transplantation

Genetic and Rare Diseases Information Center resources: Lymphosarcoma Myeloid Leukemia Acute Myeloid Leukemia Acute Non Lymphoblastic Leukemia Ovarian Cancer Chronic Lymphocytic Leukemia Leukemia, B-cell, Chronic Multiple Myeloma Myelodysplastic Syndromes Acute Lymphoblastic Leukemia Chronic Myeloid Leukemia Myelofibrosis Chronic Myeloproliferative Disorders Childhood Acute Lymphoblastic Leukemia Hodgkin Lymphoma Soft Tissue Sarcoma Neuroblastoma Renal Cell Carcinoma Lymphoma, Large-cell Lymphoblastic Lymphoma Acute Promyelocytic Leukemia Wilms' Tumor Hairy Cell Leukemia Perlman Syndrome Ovarian Germ Cell Tumor Myelodysplastic/myeloproliferative Disease Hodgkin Lymphoma, Childhood Anaplastic Plasmacytoma Neuroepithelioma

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)

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.

Eligibility


Ages Eligible for Study:	2 Years to 18 Years (Child, Adult)
Sexes Eligible for Study:	All
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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


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:	September 19, 2013

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-ABL1 negative

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-ABL1 negative

Additional relevant MeSH terms:


Lymphoma Syndrome Leukemia Neoplasms Multiple Myeloma Neoplasms, Plasma Cell Myelodysplastic Syndromes Preleukemia Neuroblastoma Kidney Neoplasms Carcinoma, Renal Cell Mucositis Plasmacytoma Myeloproliferative Disorders Myelodysplastic-Myeloproliferative Diseases	Neoplasms by Histologic Type Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Disease Pathologic Processes Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Bone Marrow Diseases

ClinicalTrials.gov processed this record on June 23, 2017