An interventional study of Photobiomodulation for prevention arm and Photobiomodulation for exploratory arm in Mucositis Oral, sponsored by Medical College of Wisconsin. Not yet recruiting at 1 site in United States. Open to participants aged Up to 30 Years. Per ClinicalTrials.gov, last updated 2026-10-06.
Sponsored by Medical College of Wisconsin · Not applicable, Interventional, and Prevention
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:
306 studies on the registry are indexed under Stomatitis; 75 are open to participants now.
This study's planned enrollment of 50 is below the median of 60 across 276 interventional studies indexed under Stomatitis.
Browse Stomatitis studies →Medical College of Wisconsin is the lead sponsor of 548 studies on the registry; 122 are open to participants now.
Of its 75 completed or terminated interventional studies of FDA-regulated products, 57 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Prospective data review of patients who did not receive light therapy
Prospective data review of patients who did receive light therapy
Device: Photobiomodulation for prevention 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.
Also known as: PBM, Light therapy
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.
Also known as: PBM, Light therapy
Evaluate the feasibility of using PBM in pediatric oncology patients.
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.
Time frame: 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.
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.
Time frame: 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.
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
Time frame: 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.
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.
Time frame: From date of enrollment until date of last PBM treatment, assessed up to 2 years.
Plan to share: Undecided
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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