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

June 16, 2026 updated by: Elissa Shulta, Medical College of Wisconsin

Photobiomodulation Therapy for the Prevention of Mucositis in Pediatric Oncology Patients

The goal of this clinical trial is to learn if light therapy can prevent 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 mouth sores related to medical treatment?

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

Participants will:

  • Complete a survey.
  • Have picture taken of their mouth to look for mouth sores.
  • Receive light therapy every day while admitted to the hospital on the cancer unit or while admitted to an alternate unit, and continue to receive light therapy in the home setting until they reach 8 days after the start of their chemotherapy cycle.

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
        • Sub-Investigator:
          • Amy Pan, PhD
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Peter Shaw, MD
        • Sub-Investigator:
          • Valerie Lohse, MSN
        • Principal Investigator:
          • Elissa Shulta, DNP
        • Sub-Investigator:
          • Sarah Joost, MSN
        • Sub-Investigator:
          • Meredith Beversdorf, BSN
        • Sub-Investigator:
          • Amberley Kemic, BSN
        • Sub-Investigator:
          • Ashley Hain, BSN

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:

  1. Current and new diagnosis patients consented upon admission if deemed eligible
  2. Ages 0-30
  3. Admitted to CW oncology/BMT inpatient unit, PICU, or West 5
  4. Chemotherapy regimen: Methotrexate ≥5 g/m2 (or ≥1 g/m2 if Trisomy 21) OR Anthracycline ≥60 mg/m2
  5. Able to speak and understand English or Spanish

Exclusion Criteria:

  1. Patients admitted on BMT service
  2. Patients currently experiencing mucositis with a CTCAE grade 4 oral mucositis or higher

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Arm
Prospective data review of patients who did not receive light therapy
Active Comparator: Prevention Arm
Prospective data review of patients who did receive light therapy
Device: Photobiomodulation for prevention arm

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.

Patients will continue to receive light therapy in the home setting through day +8 of their chemotherapy cycle using the Luminance Device.

Other Names:
  • Light therapy
  • PBM
Active Comparator: Exploratory Arm
Prospective review of patients with Trisomy 21 who did receive light therapy
Device: Photobiomodulation for exploratory arm

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.

Patients will continue to receive light therapy in the home setting through day +8 of their chemotherapy cycle using the Luminance Device.

Other Names:
  • Light therapy
  • PBM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the feasibility of using PBM in pediatric oncology patients.
Time Frame: From date of enrollment until date of last PBM treatment, assessed up to 2 years.
Feasibility of PBM will be assessed by the RN completing a survey using a 5-point Likert scale (5 being strongly agree and 1 being strongly disagree) to evaluate the ease of delivery of PBM therapy. A score of ≥3 indicates that the PBM therapy was feasible.
From date of enrollment until date of last PBM treatment, assessed up to 2 years.
Evaluate the 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.
Acceptability of PBM will be assessed by the patient/caregiver completing a survey using a 5-point Likert scale (5 being strongly agree and 1 being strongly disagree) to evaluate the patient's tolerance of the treatment. A score of ≥3 indicates acceptability of PBM therapy.
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 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 in reducing the incidence and severity of mucositis in pediatric oncology patients receiving chemotherapy.
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 number of unique patients with the value of "mucositis/stomatitis" in the oral mucosa flowsheet row. Additionally, mucositis onset, severity, and grade will be measured using the CTCAE grading scale and the ChIMES patient/caregiver survey
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)

August 1, 2026

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

September 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 (Actual)

June 22, 2026

Last Update Submitted That Met QC Criteria

June 16, 2026

Last Verified

June 1, 2026

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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