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

NCT06623305 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-10-24

No results posted yet for this study

Summary

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.

Conditions

  • Mucositis Oral

Interventions

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.

Sponsors & Collaborators

  • Medical College of Wisconsin

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2027-04-30
Completion
2027-04-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06623305 on ClinicalTrials.gov