Milwaukee, Wisconsin 53226


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.


Study summary:

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.


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


Study is Available At:


Original ID:

CDR0000069293


NCT ID:

NCT00036712


Secondary ID:

MCW-HRRC-28600


Study Acronym:


Brief Title:

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


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


Overall Status:

Recruiting


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

2 Years


Maximum Age:

18 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Cancer Institute (NCI)


Oversight Authority:

Unspecified


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Primary Purpose: Supportive Care


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

80


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Harry T. Whelan, MD
Study Chair
Medical College of Wisconsin

Study Dates

Start Date:January 2002
Primary Completion Date:August 2009
Primary Completion Type:Anticipated
Verification Date:June 2009
Last Changed Date:September 19, 2013
First Received Date:May 13, 2002

Study Outcomes

Outcome Type:Primary Outcome
Measure:Mean change in oral mucositis index (OMI) score from baseline to maximum score within 14 days posttransplant
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Mean change in pain score from baseline to maximum score within 14 days posttransplant
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Proportion of patients not experiencing ulcerative mucositis within the first 14 days posttransplant
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Time to heal
Safety Issues:False

Study Interventions

Intervention Type:Procedure
Name:management of therapy complications
Intervention Type:Procedure
Name:pain therapy

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Medical College of Wisconsin

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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