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

Primary Purpose

Chronic Myeloproliferative Disorders, Kidney Cancer, Leukemia

Status

Unknown status

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

management of therapy complications

pain therapy

About this trial

This is an interventional supportive care trial for Chronic Myeloproliferative Disorders focused on measuring 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, myelodysplastic/myeloproliferative neoplasm, unclassifiable, childhood myelodysplastic syndromes

Eligibility Criteria

2 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Medical College of Wisconsin Cancer CenterRecruiting

Outcomes

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

Full Information

NCT ID

NCT00036712

First Posted

May 13, 2002

Last Updated

September 19, 2013

Sponsor

Medical College of Wisconsin

1. Study Identification

Unique Protocol Identification Number

NCT00036712

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2009

Overall Recruitment Status

Unknown status

Study Start Date

January 2002 (undefined)

Primary Completion Date

August 2009 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Medical College of Wisconsin

4. Oversight

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

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, myelodysplastic/myeloproliferative neoplasm, unclassifiable, childhood myelodysplastic syndromes

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 2

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

management of therapy complications

Intervention Type

Procedure

Intervention Name(s)

pain therapy

Primary Outcome Measure Information:

Title

Mean change in oral mucositis index (OMI) score from baseline to maximum score within 14 days posttransplant

Title

Mean change in pain score from baseline to maximum score within 14 days posttransplant

Title

Proportion of patients not experiencing ulcerative mucositis within the first 14 days posttransplant

Secondary Outcome Measure Information:

Title

Time to heal

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Harry T. Whelan, MD

Organizational Affiliation

Medical College of Wisconsin

Official's Role

Study Chair

Facility Information:

Facility Name

Medical College of Wisconsin Cancer Center

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53226

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Clinical Trials Office - Medical College of Wisconsin Cancer C

Phone

414-805-4380

12. IPD Sharing Statement

Learn more about this trial

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

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