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

Conditions

• Mucositis Oral

Eligibility Criteria

Sex

ALL

Age

N/A - 30 Years

Healthy Volunteers

Not accepted

Interventions

• Photobiomodulation — DEVICE
  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.

Study Details

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.

Key Dates

Start date

Apr 30, 2026

Status verified

Oct 2025

Primary completion

Apr 30, 2027

Completion

Apr 30, 2027

Study Design

Enrollment

50 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Arms

• 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

Primary Outcome Measure

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. ]

Central Contacts

• Elissa Shulta, DNP
  414-266-5407
  [email protected]
• Peter Shaw, MD
  414-955-4086
  [email protected]

Locations (1)

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