A Clinical Trial of the Administration of Light Therapy to Prevent and Treat Mouth Sores in Children With Cancer (PBM)

October 22, 2025 updated by: Elissa Shulta, Medical College of Wisconsin

Photobiomodulation Therapy for the Prevention and Treatment of Mucositis in Pediatric Oncology Patients

The goal of this clinical trial is to learn if light therapy can prevent and/or treat mouth sores in children with cancer. The main questions it aims to answer are:

Is it reasonable and acceptable to provide light therapy for children with cancer?

Does light therapy prevent and treat mouth sores related to medical treatment?

Researchers will compare children who did not receive light therapy before the clinical trial to children who receive light therapy during the clinical trial to see if light therapy helps to prevent and treat mucositis.

Participants will:

  • Tell the nurse their pain score, related to their mouth sores, before receiving light therapy.
  • Have picture taken of their mouth to look for mouth sores.
  • Receive light therapy every other day while admitted to the hospital on the cancer unit or while admitted to an alternate unit.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Peter Shaw, MD
  • Phone Number: 414-955-4086
  • Email: pshaw@mcw.edu

Study Locations

  • United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Peter Shaw, MD
        • Sub-Investigator:
          • Valerie Lohse, MSN
        • Sub-Investigator:
          • Cynthia Flanagan, BSN
        • Principal Investigator:
          • Elissa Shulta, DNP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Admitted to oncology unit, PICU, or on an alternate acute care unit.
  • Diagnosis:
  • Following diagnoses until achieve count recover (ANC≥500), the patient has no clinical signs of mucositis, or is discharged i. ALL interim-maintenance high dose Methotrexate ii. ALL with trisomy 21 receiving high dose Methotrexate iii. AML iv. Neuroblastoma (excluding admissions for antibody treatment) v. Burkitt lymphoma vi. Osteosarcoma receiving high dose Methotrexate vii. Germ cell tumors receiving Etoposide viii. Rhabdomyosarcoma ix. Ewing sarcoma
  • Head/neck cancers receiving radiation
  • Able to speak and understand English or Spanish

Exclusion Criteria:

  • Unwilling to participate
  • Do not meet eligibility criteria outline above

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Retrospective Arm
Retrospective data review of patients who did not receive light therapy
Active Comparator: Prospective Arm
Prospective data review of patients who receive light therapy
Device: Photobiomodulation
Light therapy will be administered using the cluster probe on the external cheeks bilaterally and intraorally using the lollipop probe for patients ≥7 years of age. Patients < 7 years of age will not receive intraoral treatment with the lollipop. Instead, they will be asked to open their mouth while the covered cluster probe is held externally to treat their intraoral membranes. Each treatment (both external cheeks and intraoral buccal region) will be administered over 1 min with a Modulation Frequency 2.5Hz, Skin Conduction nS 001, and Beam Power mW 000, for a total treatment time of 3 minutes.
Other Names:
  • PBM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the feasibility and acceptability of using PBM in pediatric oncology patients.
Time Frame: From date of enrollment until date of last PBM treatment, assessed up to 2 years.
This will be assessed through a questionnaire completed by the RN administering the PBM therapy and will focus on the patient's tolerance level rated on a numerical scale, the nurse's perception of feasibility, and length of treatment in minutes.
From date of enrollment until date of last PBM treatment, assessed up to 2 years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the effectiveness of using PBM based on mucositis onset
Time Frame: From date of enrollment until date of last PBM treatment, assessed up to 2 years.
This will be assessed by the study team through analysis of retrospective and prospective data entered into the electronic health record based on the first day a patient has reported oral mucosal pain or oral ulcers/sloughing.
From date of enrollment until date of last PBM treatment, assessed up to 2 years.
Evaluate the effectiveness of using PBM based on mucositis severity.
Time Frame: From date of enrollment until date of last PBM treatment, assessed up to 2 years.
This will be assessed by the study team through analysis of retrospective and prospective data entered into the electronic health record, defined using the CTCAE oral mucositis grading scale.
From date of enrollment until date of last PBM treatment, assessed up to 2 years.
Evaluate the effectiveness of using PBM based on mucositis duration.
Time Frame: From date of enrollment until date of last PBM treatment, assessed up to 2 years.
This will be assessed by the study team through analysis of retrospective and prospective data entered into the electronic health record, defined as the first day a patient has reported oral mucosal pain or oral ulcers/sloughing until the patient no longer reports oral mucosal pain or no longer has clinical signs of mucositis.
From date of enrollment until date of last PBM treatment, assessed up to 2 years.
Evaluate the effectiveness of using PBM based on length of stay.
Time Frame: From date of enrollment until date of last PBM treatment, assessed up to 2 years.
This will be assessed by the study team through analysis of retrospective and prospective data entered into the electronic health record, defined as the period of time between the patient's admission date and their discharge date.
From date of enrollment until date of last PBM treatment, assessed up to 2 years.
Evaluate the effectiveness of using PBM based on narcotic usage.
Time Frame: From date of enrollment until date of last PBM treatment, assessed up to 2 years.
This will be assessed by the study team through analysis of retrospective and prospective data entered into the electronic health record, defined as any narcotic administration documented in the Medication Administration Record, such as PRN narcotics (PO or IV), scheduled narcotics, or use of Patient-Controlled Analgesic.
From date of enrollment until date of last PBM treatment, assessed up to 2 years.
Evaluate the effectiveness of using PBM based on nutritional support.
Time Frame: From date of enrollment until date of last PBM treatment, assessed up to 2 years.
This will be assessed by the study team through analysis of retrospective and prospective data entered into the electronic health record, defined as the administration of TPN or lipids as documented in the Medication Administration Record.
From date of enrollment until date of last PBM treatment, assessed up to 2 years.
Evaluate the effectiveness of using PBM based on pain score.
Time Frame: From date of enrollment until date of last PBM treatment, assessed up to 2 years.

This will be assessed by the study team through analysis of retrospective and prospective data entered into the electronic health record, defined as the numeral rating that patient provides to the PBM RN using an age-appropriate pain scale specifically related to oral or throat pain.

  • 0 - 10: Verbal Numeric Rating Scale (VNRS)- Use for children ≥8 years old who understand the concept of order and number
  • Bieri Faces- Use for children > 3 years old who can understand the scale
  • FLACC - Revised (Face- Legs- Activity- Cry- Consolability)- Use for infants, toddlers, children with developmental delay, or any child who is unable to use a self-report scale (0-10 or Bieri faces)
From date of enrollment until date of last PBM treatment, assessed up to 2 years.
Evaluate the effectiveness of using PBM based on MBI CLABSI rate.
Time Frame: From date of enrollment until date of last PBM treatment, assessed up to 2 years.
This will be assessed by the study team through analysis of retrospective and prospective data entered into the electronic health record, defined as the rate of MBI CLABSIs per 1,000 line days.
From date of enrollment until date of last PBM treatment, assessed up to 2 years.
Evaluate the effectiveness of using PBM based on Glutamine administration.
Time Frame: From date of enrollment until date of last PBM treatment, assessed up to 2 years.
This will be assessed by the study team through analysis of retrospective and prospective data entered into the electronic health record, defined as a documented administration as "given" in the Medication Administration Record for oral glutamine in the past 24 hours.
From date of enrollment until date of last PBM treatment, assessed up to 2 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical College of Wisconsin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

September 27, 2024

First Submitted That Met QC Criteria

October 1, 2024

First Posted (Actual)

October 2, 2024

Study Record Updates

Last Update Posted (Estimated)

October 24, 2025

Last Update Submitted That Met QC Criteria

October 22, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO00051962

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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