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

Conditions

• Mucositis Oral

Eligibility Criteria

Sex

ALL

Age

N/A - 30 Years

Healthy Volunteers

Not accepted

Interventions

• Photobiomodulation for prevention arm — 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. Patients will continue to receive light therapy in the home setting through day +8 of their chemotherapy cycle using the Luminance Device.
• Photobiomodulation for exploratory arm — 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. Patients will continue to receive light therapy in the home setting through day +8 of their chemotherapy cycle using the Luminance Device.

Study Details

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.

Key Dates

First listed

Oct 2, 2024

Start date

Aug 31, 2026

Status verified

Jun 2026

Primary completion

Aug 31, 2027

Completion

Sep 30, 2027

Study Design

Enrollment

50 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• 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
• Active Comparator: Exploratory Arm
  Prospective review of patients with Trisomy 21 who did receive light therapy

Primary Outcome Measure

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. ]

Central Contacts

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

Locations (1)

Find similar trials in Milwaukee, WI

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