NCT00036712

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 13, 2002

Completed
9 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Last Updated

September 20, 2013

Status Verified

June 1, 2009

Enrollment Period

7.6 years

First QC Date

May 13, 2002

Last Update Submit

September 19, 2013

Conditions

Multiple Myeloma and Plasma Cell NeoplasmChronic Myeloproliferative DisordersKidney CancerLeukemiaLymphomaMyelodysplastic SyndromesMyelodysplastic/Myeloproliferative NeoplasmsNeuroblastomaOral ComplicationsOvarian CancerPainSarcoma

Keywords

recurrent childhood acute lymphoblastic leukemiarefractory multiple myelomarecurrent childhood rhabdomyosarcomadisseminated neuroblastomarecurrent neuroblastomarecurrent Wilms tumor and other childhood kidney tumorsrecurrent childhood lymphoblastic lymphomastage III chronic lymphocytic leukemiastage IV chronic lymphocytic leukemiarecurrent childhood acute myeloid leukemiarelapsing chronic myelogenous leukemiarefractory chronic lymphocytic leukemiachronic phase chronic myelogenous leukemiaaccelerated phase chronic myelogenous leukemiablastic phase chronic myelogenous leukemiaprimary myelofibrosischildhood acute promyelocytic leukemia (M3)refractory hairy cell leukemiaoral complicationsrecurrent/refractory childhood Hodgkin lymphomade novo myelodysplastic syndromespreviously treated myelodysplastic syndromessecondary myelodysplastic syndromespainrecurrent childhood small noncleaved cell lymphomarecurrent childhood large cell lymphomapreviously treated childhood rhabdomyosarcomachildhood malignant ovarian germ cell tumorchildhood chronic myelogenous leukemiaatypical chronic myeloid leukemia, BCR-ABL1 negativemyelodysplastic/myeloproliferative neoplasm, unclassifiablechildhood myelodysplastic syndromes

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

  • Time to heal

Interventions

management of therapy complicationsPROCEDURE
pain therapyPROCEDURE

Eligibility Criteria

Age2 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Medical College of Wisconsin Cancer Center

Milwaukee, Wisconsin, 53226, United States

RECRUITING

MeSH Terms

Conditions

Myeloproliferative DisordersKidney NeoplasmsLeukemiaLymphomaMultiple MyelomaNeoplasms, Plasma CellMyelodysplastic SyndromesMyelodysplastic-Myeloproliferative DiseasesNeuroblastomaOvarian NeoplasmsPainSarcomaPrecursor Cell Lymphoblastic Leukemia-LymphomaWilms TumorLeukemia, Lymphocytic, Chronic, B-CellLeukemia, Myeloid, Chronic-PhaseLeukemia, Myeloid, Accelerated PhaseBlast CrisisPrimary MyelofibrosisLeukemia, Hairy CellRecurrenceBurkitt LymphomaDendritic Cell Sarcoma, InterdigitatingOvarian Germ Cell CancerLeukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative

Interventions

Analgesia

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesNeoplasms by Histologic TypeLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersNeuroectodermal Tumors, Primitive, PeripheralNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleGenital Neoplasms, FemaleGenital DiseasesEndocrine System DiseasesGonadal DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsNeoplasms, Connective and Soft TissueLeukemia, LymphoidNeoplasms, Complex and MixedNeoplastic Syndromes, HereditaryGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesLeukemia, B-CellChronic DiseaseDisease AttributesPathologic ProcessesLeukemia, Myelogenous, Chronic, BCR-ABL PositiveLeukemia, MyeloidCell Transformation, NeoplasticCarcinogenesisNeoplastic ProcessesEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphoma, B-CellLymphoma, Non-HodgkinHistiocytic Disorders, MalignantHistiocytosis

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia

Study Officials

  • Harry T. Whelan, MD

    Medical College of Wisconsin

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
SUPPORTIVE CARE
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 13, 2002

First Posted

January 27, 2003

Study Start

January 1, 2002

Primary Completion

August 1, 2009

Last Updated

September 20, 2013

Record last verified: 2009-06

Locations

US(1)