← Back to Search

Chemotherapy

LED Therapy for Mucositis Prevention in Children Undergoing Bone Marrow Transplant

Phase 2

Waitlist Available

Research Sponsored by Medical College of Wisconsin

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients undergoing a myeloablative conditioning regimen comprising chemotherapy with or without radiotherapy prior to a first allogeneic bone marrow transplantation

No photophobia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial will compare LED therapy to no LED therapy to see if it can prevent mucositis of the mouth in children.

Who is the study for?

This trial is for children aged 2-18 undergoing chemotherapy with or without radiation before a bone marrow transplant. They must be able to handle LED therapy and oral exams, not pregnant, use contraception if applicable, and have no lung issues increasing intubation risk.Check my eligibility

What is being tested?

The study is testing whether light-emitting diode (LED) therapy can prevent mouth sores in kids receiving chemo/radiation before a bone marrow transplant. It's a phase II trial where the effectiveness of LED therapy is compared randomly.See study design

What are the potential side effects?

Potential side effects may include discomfort from the LED device or reactions in sensitive individuals. However, since it's non-invasive, serious side effects are unlikely compared to drug treatments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am preparing for my first bone marrow transplant with intensive treatment.

Select...

I do not have sensitivity to light.

Select...

My lungs work well enough not to need a breathing tube in the first 3 weeks after a transplant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Medical College of WisconsinLead Sponsor

609 Previous Clinical Trials

1,162,521 Total Patients Enrolled

Harry T. Whelan, MDStudy ChairMedical College of Wisconsin

2 Previous Clinical Trials

27 Total Patients Enrolled

Media Library

Chemotherapy (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT00036712 — Phase 2

Oral Complications Research Study Groups:

Oral Complications Clinical Trial 2023: Chemotherapy Highlights & Side Effects. Trial Name: NCT00036712 — Phase 2

Chemotherapy (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00036712 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has this therapeutic intervention been officially sanctioned by the FDA?

"Due to limited evidence of efficacy, this treatment received a score of 2 as far as safety is concerned. Nevertheless, there are data points that suggest it can be used safely in the context of this Phase 2 trial."

Answered by AI

Does the enrollment for this experiment include elderly people?

"This medical study is recruiting minors between 2 and 18 years of age."

Answered by AI

Is enrollment into this research still available?

"To be eligible for this medical trial, applicants must have been diagnosed with leukemia and fall between the ages of 2-18. The research team is currently recruiting a total of 80 patients."

Answered by AI

Is the recruitment process for this clinical trial ongoing?

"Clinicaltrials.gov denotes that this drug trial is not currently accepting new participants, as the study was posted on January 1st 2002 and edited lastly on September 19th 2013. However, there are numerous other studies actively enrolling people at present time with a total of 8194 recruiting sites listed."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2002. "Light-Emitting Diode Therapy in Preventing Mucositis in Children Receiving Chemotherapy With or Without Radiation Therapy Before Bone Marrow Transplantation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00036712.

All > Chronic Low Back Pain > Paid Studies Wisconsin