Photobiomodulation for Mouth Sores
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether photobiomodulation, a type of light therapy, can prevent mouth sores in individuals undergoing a specific bone marrow transplant. The study tests three methods of applying this therapy: inside the mouth, outside the mouth, and a combination of both. Individuals scheduled for a myeloablative allogeneic hematopoietic cell transplant who have not recently used similar light therapy may qualify. Participants will join one of the three treatment groups and receive daily therapy to determine its effectiveness in reducing mouth sores. As a Phase 2 trial, this research focuses on assessing the treatment's efficacy in an initial, smaller group.
Do I need to stop my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Studies have shown that photobiomodulation (PBM) is generally safe and well-tolerated for treating mouth sores. A review of 13 clinical trials found PBM to be a painless treatment with no reported side effects, effective both inside and outside the mouth. An LED-based device used inside the mouth for PBM also proved safe and effective in reducing severe mouth sores in patients with head and neck conditions.
While PBM is usually safe, researchers continue to collect more long-term safety information. Prospective trial participants should know that PBM is generally considered a safe option for managing mouth sores caused by medical treatments.12345Why are researchers excited about this trial's treatments?
Photobiomodulation is unique because it uses light therapy to treat mouth sores, unlike traditional treatments like medicated mouthwashes or topical gels. Researchers are excited about this approach because it offers a non-invasive, painless alternative that could speed up healing. The treatment involves both intraoral and extraoral devices, with the intraoral device being small and comfortable enough to fit in the mouth, while the extraoral device uses dual-headed probes to target the sores from outside the mouth. This dual-action delivery method could enhance effectiveness and provide faster relief compared to conventional therapies.
What evidence suggests that this trial's photobiomodulation treatments could be effective for preventing oral mucositis?
Research has shown that photobiomodulation therapy (PBMT) can reduce painful mouth sores in patients undergoing treatments like stem cell transplants. This trial will evaluate different PBMT approaches. Participants in one arm will receive combined intraoral and extraoral PBMT, which studies suggest can prevent severe sores and improve quality of life. Another arm will focus on intraoral PBMT, using a small LED device inside the mouth, which has proven safe and effective in reducing sores. A separate arm will study extraoral PBMT, applying light therapy outside the mouth, which also helps lessen the severity and duration of these sores. Overall, PBMT offers a promising method to prevent and treat mouth sores in various situations.46789
Are You a Good Fit for This Trial?
This trial is for patients undergoing myeloablative allogeneic hematopoietic stem cell transplantation (alloHSCT) to prevent severe oral mucositis. Participants must be able to receive daily photobiomodulation therapy and commit to regular clinic visits and symptom diaries.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive daily photobiomodulation therapy from the beginning of transplant conditioning through Day +20 after transplantation
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Photobiomodulation
Trial Overview
The study tests if photobiomodulation can prevent oral mucositis in alloHSCT patients. It compares three methods: intraoral, extraoral, and combined treatments, with participants randomly assigned to one of these groups.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Intraoral PBMT device: The THOR intraoral PBMT device emits LED light with an irradiance of 50 mW/cm2 and, when applied for 60 seconds, delivers 3 J/cm2. It is a handheld device with an array of LEDs covered by smooth glass. The therapeutic area is small enough (similar to a popsicle) to place in the mouth comfortably.
Extraoral PBMT device: The extraoral PBMT device is a dual headed probe designed to be connected to the LX2.3 Laser and LED Therapy System. It consists of two high-powered probes designed to emit 850nm light at an intensity of 240 m/cm2. The device is dual-headed in order to treat both sides of the head simultaneously without the need for a sperate control unit.
Participants in this arm will receive both intraoral and extraoral photobiomodulation.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Brigham and Women's Hospital
Lead Sponsor
Citations
a randomized clinical trial - PMC
PBM appears to be a safe and effective approach for the prevention of MTX-induced OM in pediatric patients with hematologic cancers.
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Evaluate the effectiveness of using PBM based on mucositis severity. This will be assessed by the study team through analysis of retrospective and prospective ...
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oncnursingnews.com
oncnursingnews.com/view/intraoral-photobiomodulation-device-safe-reduces-oral-mucositis-in-hncIntraoral Photobiomodulation Device Safe, Reduces Oral ...
An LED-based intraoral device for photobiomodulation therapy was safe and reduced severe oral mucositis in patients with head and neck ...
Effect of photobiomodulation on the severity of oral mucositis ...
Photobiomodulation is a well-consolidated and effective therapy for the treatment and prevention of severe OM, and is associated with a cost reduction of the ...
Photobiomodulation Therapy in Oral Mucositis and ...
Photobiomodulation therapy (PBMT) is an effective treatment modality, which has the significant advantage of enhancing a patient's quality of life (QoL)
The potential effect of photobiomodulation on oral ...
In this review of 13 randomized clinical trials, PBMT was consistently found to be a safe, painless, and well-tolerated treatment option. No documented adverse ...
Monte Carlo based dosimetry of extraoral ...
This study reports on the development of an extraoral PBMT treatment protocol for preventing and/or treating oral mucositis. To the best of our ...
A Pilot Study Comparing Intraoral and Transcutaneous ...
Background: Photobiomodulation (PBM) therapy has shown potential in managing oral mucositis (OM), a frequent and painful side effect of radiotherapy or ...
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