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

Sponsor:	Medical College of Wisconsin
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00036712

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 Diseases Neuroblastoma Oral Complications Ovarian Cancer Pain Sarcoma	Procedure: management of therapy complications Procedure: pain therapy	Phase II

Study Type:	Interventional
Study Design:	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: aceruloplasminemia hemophilia

MedlinePlus related topics: Bone Marrow Transplantation Cancer Kidney Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood Lymphoma Multiple Myeloma 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)

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
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:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Medical College of Wisconsin Cancer Center ( Harry T. Whelan )
Study ID Numbers:	CDR0000069293, MCW-HRRC-28600, MCW-CHW-0070, NCI-V02-1699
Study First Received:	May 13, 2002
Last Updated:	June 9, 2009
ClinicalTrials.gov Identifier:	NCT00036712 History of Changes
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

chronic idiopathic 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

Additional relevant MeSH terms:

Mouth Diseases
Neuroectodermal Tumors, Primitive
Urogenital Neoplasms
Urologic Neoplasms
Neoplasms, Connective and Soft Tissue
Preleukemia
Pathologic Processes
Neoplasms by Site
Hemorrhagic Disorders
Cardiovascular Diseases
Kidney Diseases
Endocrine Gland Neoplasms
Immunoproliferative Disorders
Mucositis
Immune System Diseases

Hematologic Diseases
Myeloproliferative Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Carcinoma
Multiple Myeloma
Neuroectodermal Tumors
Neoplasms
Sarcoma
Neoplasms, Neuroepithelial
Neoplasms, Glandular and Epithelial
Precancerous Conditions
Gastrointestinal Diseases
Gonadal Disorders
Blood Protein Disorders

ClinicalTrials.gov processed this record on November 30, 2009