Photobiomodulation Therapy for Mouth Sores from Bone Marrow Transplant

Overseen By Kentaro Ikeda, DDS,MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dana-Farber Cancer Institute

Disqualifiers: Radiation therapy, Photosensitivity, Palifermin, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 3 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new light therapy to prevent mouth sores in individuals undergoing a specific type of bone marrow transplant. The treatment uses a device called the THOR LX2.3 with LED Lollipop to deliver light inside the mouth daily during the transplant process. It targets individuals preparing for this transplant who have not recently received light therapy or radiation to the head and neck. Those about to undergo a transplant and interested in exploring this new method to prevent painful mouth sores might consider participating in this trial. As an unphased trial, it offers a unique opportunity to explore innovative treatment options that could enhance the transplant experience.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, it mentions specific treatments and conditions that would exclude you from participating, such as recent intraoral PBMT or planned use of palifermin.

What prior data suggests that the THOR LX2.3 with LED Lollipop is safe for preventing oral mucositis?

Research has shown that photobiomodulation therapy (PBMT) is usually safe and well-tolerated. Studies have found that PBMT can reduce swelling and aid in wound healing, which is promising for preventing mouth sores. The device used in this trial, the THOR LX2.3 with LED Lollipop, has been tested in similar situations as a light therapy tool.

Specific data about side effects from these sources is not available, but PBMT is generally used without major safety concerns. As this is an early-stage trial, extensive safety data might not yet exist. However, the use of similar devices in the past suggests a low risk of serious side effects. Participants can expect the treatment to be gentle, as it is designed to promote healing without causing harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for mouth sores caused by bone marrow transplants, which typically involve pain management and protective oral rinses, Photobiomodulation Therapy (PBMT) with the THOR LX2.3 and LED Lollipop is a novel approach that uses light to promote healing. This treatment is unique because it leverages specific wavelengths of light to stimulate cellular repair and reduce inflammation directly in the mouth. Researchers are excited about this therapy because it offers a non-invasive, drug-free alternative that could potentially speed up recovery and provide relief faster than traditional methods.

What evidence suggests that the THOR LX2.3 with LED Lollipop is effective for preventing mouth sores from bone marrow transplant?

Studies have shown that photobiomodulation therapy (PBMT) can help prevent mouth sores, or oral mucositis, in people undergoing bone marrow transplants. The trial will use the THOR LX2.3 with LED Lollipop device to deliver PBMT. This treatment uses light to reduce swelling and aid in mouth healing. Research indicates that PBMT can lessen the severity and duration of these painful sores. Specifically, patients using devices like the THOR LX2.3 with LED Lollipop have experienced fewer and less severe mouth sores. Early findings suggest that this therapy could effectively reduce the discomfort associated with bone marrow transplants. ^{1 4 5 6 7}

Who Is on the Research Team?

Kentaro Ikeda, DDS, MPH

Principal Investigator

Brigham and Women's Hospital

Nathaniel S. Treister, DMD, DMSc

Principal Investigator

Brigham and Women's Hospital

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are about to receive a bone marrow transplant and have agreed to the study. It's not for those who've had photobiomodulation therapy recently, radiation on their head or neck, issues with light sensitivity, or will be treated with palifermin.

Inclusion Criteria

Ability to understand and the willingness to sign a written informed consent document

I am scheduled for a specific bone marrow transplant with FluBu4 and Tac-Mtx.

Exclusion Criteria

I have had radiation therapy to my head or neck.

I have received PBMT in my mouth within the last month before my stem cell transplant.

I am scheduled to receive palifermin for mouth sore prevention.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Conditioning Chemotherapy

Participants receive conditioning chemotherapy as part of the transplant procedure

1-2 weeks

Treatment

Participants receive daily intraoral photobiomodulation therapy (PBMT) from the start of conditioning chemotherapy to day +20 or until discharge

Up to 3 weeks

Daily visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• THOR LX2.3 with LED Lollipop

Trial Overview The trial tests if a special LED device called THOR LX2.3 can prevent mouth sores in patients getting intense chemotherapy before a bone marrow transplant. Participants will use this LED Lollipop daily during treatment.

How Is the Trial Designed?

Group I: INTRAORAL PBMT IN PATIENTS UNDERGOING alloHCT Experimental Treatment 1 Intervention

The research study procedures include: screening for eligibility and study treatment including daily PBMT and clinical evaluations. Participants will receive the study treatment daily from the start of conditioning chemotherapy to day +20, or discharge (if you are able to be discharged from the hospital prior to day +20), whichever occurs first -THOR LX2.3 with LED Lollipop

THOR LX2.3 with LED Lollipop is already approved in European Union, United States, Brazil for the following indications:

Approved in European Union as Photobiomodulation Therapy for:

• Prevention of oral mucositis in patients undergoing hematopoietic stem cell transplantation
• Treatment of oral mucositis in patients with head and neck cancer

Approved in United States as Low-Level Laser Therapy for:

• Prevention of oral mucositis in patients undergoing hematopoietic stem cell transplantation
• Treatment of oral mucositis in patients with head and neck cancer

Approved in Brazil as Light Therapy for:

• Prevention of oral mucositis in patients undergoing hematopoietic stem cell transplantation
• Treatment of oral mucositis in patients with head and neck cancer

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

THOR Photomedicine Ltd

Collaborator

Trials

1

Recruited

20+

Published Research Related to This Trial

Photobiomodulation (PBM) therapy is recommended for the prevention of oral mucositis (OM) in cancer patients undergoing specific treatments, such as hematopoietic stem cell transplantation and head and neck radiotherapy, based on a systematic review of the literature.

Currently, there is insufficient evidence to provide guidelines for the treatment of established OM or chemotherapy-related OM, indicating a need for further research in these areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review of photobiomodulation for the management of oral mucositis in cancer patients and clinical practice guidelines. Zadik, Y., Arany, PR., Fregnani, ER., et al.[2021]

In a study involving 80 pediatric patients with acute lymphoblastic leukemia undergoing high-dose methotrexate treatment, both low-level laser therapy (LLLT) and light-emitting diode therapy (LEDT) were found to have similar efficacy in preventing and treating oral mucositis, with incidence rates of 10% and 12.5%, respectively.

Both treatment groups took the same amount of time to resolve oral mucositis and pain, indicating that LEDT can be considered an effective alternative to LLLT for managing this condition in pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-level laser or LED photobiomodulation on oral mucositis in pediatric patients under high doses of methotrexate: prospective, randomized, controlled trial. Guimaraes, DM., Ota, TMN., Da Silva, DAC., et al.[2021]

Low-level light therapy (LLLT) shows promising benefits in periodontal and dental implant treatments, demonstrating biostimulatory, anti-inflammatory, and analgesic effects that can enhance healing and reduce inflammation.

Despite the positive findings, there is significant variability in study designs and light irradiation parameters, making it difficult to establish standardized evidence-based protocols for clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photobiomodulation in Periodontology and Implant Dentistry: Part 1. Gholami, L., Asefi, S., Hooshyarfard, A., et al.[2020]

Low-level laser therapy (LLLT), also known as PhotoBioModulation (PBM), has strong evidence supporting its effectiveness in preventing and treating oral mucositis in patients undergoing radiotherapy for head and neck cancer or high-dose chemotherapy.

Recent advancements in LLLT/PBM technology and understanding of its mechanisms may allow it to manage a wider range of cancer treatment side effects, potentially improving patient adherence to therapy and overall quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photobiomodulation or low-level laser therapy in the management of cancer therapy-induced mucositis, dermatitis and lymphedema. Bensadoun, RJ.[2019]

In a randomized double-blinded trial involving 50 patients with symptomatic geographic tongue, low-level laser therapy (LLLT) using a 660-nm diode laser significantly reduced pain and burning sensations compared to a control group, particularly noted at follow-up visits T2 and T3.

LLLT not only alleviated discomfort but also promoted healing, suggesting it can enhance the quality of life for patients suffering from geographic tongue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photobiomodulation Effect of Low-level Laser Therapy as a Palliative Treatment of Symptomatic Geographic Tongue (A Double-blinded Randomized Clinical Trial). Saad, I.[2022]

In a study of 26 patients with oral squamous cell carcinoma undergoing treatment, low-level laser therapy (LLLT) significantly reduced the incidence and severity of oral mucositis, with 72.7% of the LLLT group achieving normal mucosa by week 5 compared to only 20% in the control group.

The study found no significant differences in side effects or medication use between the LLLT and control groups, indicating that LLLT is a safe intervention for managing mucositis during cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photobiomodulation with low-level laser therapy reduces oral mucositis caused by head and neck radio-chemotherapy: prospective randomized controlled trial. Marín-Conde, F., Castellanos-Cosano, L., Pachón-Ibañez, J., et al.[2019]

Low-level laser therapy (LLLT) significantly reduces the risk of developing oral mucositis (OM) in head and neck cancer patients undergoing chemotherapy or radiation, with a relative risk reduction of 2.03 compared to placebo.

LLLT not only helps prevent OM but also significantly decreases the severity and duration of symptoms, reducing the number of days with severe OM by an average of 4.38 days compared to placebo, without increasing side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review with meta-analysis of the effect of low-level laser therapy (LLLT) in cancer therapy-induced oral mucositis. Bjordal, JM., Bensadoun, RJ., Tunèr, J., et al.[2022]

Photobiomodulation therapy (PBM-T) significantly reduces the severity of oral mucositis (OM) in cancer patients, as shown in a study involving 56 participants who received treatment over 4 weeks.

Combining PBM-T with photodynamic therapy (PDT) not only enhances the effectiveness of the treatment but also accelerates the healing process, reducing the time for lesion resolution from 15 days to 11 days.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photobiomodulation and photodynamic therapy for the treatment of oral mucositis in patients with cancer. Pires Marques, EC., Piccolo Lopes, F., Nascimento, IC., et al.[2020]

Photobiomodulation therapy (PBMT) is a safe and effective treatment for oral mucositis, a painful complication following hematopoietic stem cell transplantation.

Extraoral delivery of PBMT offers clinical advantages but requires careful dosimetric planning to ensure effective treatment, as light must pass through additional tissue layers before reaching the oral mucosa.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Path to an Evidence-Based Treatment Protocol for Extraoral Photobiomodulation Therapy for the Prevention of Oral Mucositis. Adnan, A., Yaroslavsky, AN., Carroll, JD., et al.[2022]

Photobiomodulation therapy (PBMt) significantly reduced pain in patients with oral ulcers from chronic graft-versus-host disease (cGVHD), with 85.7% of treatment sessions resulting in less pain immediately after therapy.

The average pain reduction was 73.4%, and the relief lasted for about 6.5 days, with no reported adverse effects, indicating PBMt's potential as a safe and effective pain management option for refractory cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photobiomodulation (low-level laser) therapy for immediate pain relief of persistent oral ulcers in chronic graft-versus-host disease. Finfter, O., Avni, B., Grisariu, S., et al.[2021]

Low-level laser therapy (LLLT) can protect normal human lymphoblasts from ionizing radiation damage, but it does not provide the same protection for human leukemia cells, which may actually become more sensitive to radiation after LLLT treatment.

This study indicates that LLLT may not only fail to protect malignant cells during cancer treatment but could also enhance their susceptibility to radiation therapy, highlighting the need for careful consideration in clinical applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of pre-radiation exposure to LLLT of normal and malignant cells. Barasch, A., Raber-Durlacher, J., Epstein, JB., et al.[2018]

Citations

1. withpower.com withpower.com/trial/phase-stomatitis-5-2022-7dd15

Photobiomodulation Therapy for Mouth Sores from Bone ... This trial is testing a light therapy device called THOR LX2.3 with LED Lollipop to prevent painful mouth sores in patients undergoing a specific type of ...

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05335434/intraoral-photobiomodulation-therapy-to-prevent-oral-mucositis-in-patients-undergoing-hematopoietic-cell-transplantation

Intraoral Photobiomodulation Therapy to Prevent Oral ... This is a single center pilot study evaluating intraoral photobiomodulation for the prevention of oral mucositis in patients undergoing ...

3. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK587336/

Photobiomodulation in the management of oral mucositis for ... This chapter covers general trial methods, statistical analysis and governance. Details of the health economic and qualitative methods and analyses are ...

4. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2023-00178

Photobiomodulation Therapy for the Treatment of Oral ... This phase II trial studies how well photobiomodulation (PBM) therapy using the Thor LX2.3 therapy system works in treating oral chronic graft-versus-host ...

5. dana-farber.org dana-farber.org/clinical-trials/22-036

A Single Center Pilot Study of Intraoral Photobiomodulation ... This is a single center pilot study evaluating intraoral photobiomodulation for the prevention of oral mucositis in patients undergoing myeloablative ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05675930

A Study of Photobiomodulation (PBM) Therapy in People ... The purpose of this study is to find out whether photobiomodulation/PBM therapy using the Thor LX2.3 therapy system is a safe and effective treatment for oral ...

7. thorlaser.com thorlaser.com/

THOR Laser: Photobiomodulation (PBM Therapy) Low Level ... LLLT is a laser or LED light therapy that improves tissue repair (skin wounds, muscle, tendon, bone, nerves), reduces inflammation and reduces pain.