Myeloablative Allogeneic Hematopoietic Cell TransplantationNCT05335434
Intraoral Photobiomodulation Therapy to Prevent Oral Mucositis in Patients Undergoing Hematopoietic Cell Transplantation
A study testing THOR LX2.3 with LED Lollipop in people with Myeloablative Allogeneic Hematopoietic Cell Transplantation and Intraoral Photobiomodulation Therapy, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial summary
This is a single center pilot study evaluating intraoral photobiomodulation for the prevention of oral mucositis in patients undergoing myeloablative allogeneic hematopoietic cell transplantation (alloHCT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myeloablative Allogeneic Hematopoietic Cell Transplantation, Intraoral Photobiomodulation Therapy, Oral Mucositis
- What is being tested?
- THOR LX2.3 with LED Lollipop
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jun 2022to 19 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Planned to undergo myeloablative allogeneic HCT using FluBu4 conditioning and Tac-Mtx GVHD prophylaxis.
- Age ≥18 years.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Participants who have had treatment with intraoral PBMT within four weeks of admission for HSCT.
- Participants who have a history of radiation therapy to the head and neck.
- Participants who have a history of photosensitivity or underlying disease with known photosensitivity.
- Participants who are planned to receive palifermin for OM prevention.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Kentaro Ikeda, DDS, DMSc, 617-732-6570, kikeda4@bwh.harvard.edu
Kentaro Ikeda, DDS, MPH
About this study
Official title: A Single Center Pilot Study of Intraoral Photobiomodulation Therapy for the Prevention of Oral Mucositis in Patients Undergoing Myeloablative Allogeneic Hematopoietic Cell Transplantation
This is a single center pilot study evaluating intraoral photobiomodulation for the prevention of oral mucositis in patients undergoing myeloablative allogeneic hematopoietic cell transplantation (alloHCT). Patients who are planned for alloHCT will receive daily intraoral photobiomodulation therapy (PBMT) using a novel LED device.
The name of the study device involved in this study is:
- THOR LX2.3 with LED Lollipop
Read the detailed description
As part of a transplant procedure patients will receive chemotherapy in a conditioning regimen in preparation of alloHCT as well as immunosuppressive medications to help prevent graft-versus-host disease ("GVHD prophylaxis"). Together, these treatments will put patients at risk for developing side effects. A common side effect is oral mucositis (OM), in which mouth sores develop making eating and speaking difficult and painful.
Photobiomodulation therapy (PBMT) is a light-based therapy that reduces inflammation and enhances wound healing. PBMT delivered inside the mouth has been shown to reduce OM in patients undergoing alloHCT.
The name of the study device involved in this study is:
- THOR LX2.3 with LED Lollipop
This research study is a Pilot Study, which is the first time that investigators are examining this LED based intraoral PBMT.
The U.S. Food and Drug Administration (FDA) has not approved PBMT for this specific disease but it has been approved for other uses.
The research study procedures include: screening for eligibility and study treatment including daily PBMT and clinical evaluations.
Participants will receive 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.
It is expected that about 20 people will take part in this research study
- Conditions
- Myeloablative Allogeneic Hematopoietic Cell Transplantation, Intraoral Photobiomodulation Therapy, Oral Mucositis, Mucosal Ulcer
- Being tested
- THOR LX2.3 with LED Lollipop
- Keywords
- Myeloablative Allogeneic Hematopoietic Cell Transplantation (HCT), Intraoral Photobiomodulation Therapy, Oral Mucositis, Mucosal Ulcer
- Medical subject headings
- Stomatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THOR LX2.3 with LED LollipopDevice
The intraoral PBMT device will be placed inside of the mouth to deliver the therapeutic light. Each treatment is approximately 2-3 minutes in duration. PBMT will be administered daily starting from the start of conditioning through day +20, or discharge if prior to day +20, with 27 consecutive days defined as a maximum PBMT treatment duration
| Study group | Role | What they receive |
|---|---|---|
| INTRAORAL PBMT IN PATIENTS UNDERGOING alloHCT | Experimental | 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 Receives: Device: THOR LX2.3 with LED Lollipop |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of severe Oral Mucositis
Defined as the total number of days between day 0 and day +20 on which severe (WHO grade 3 or 4) OM was reported
Measured: 20 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start10 Jun 2022
- Primary completion20 Jun 2026 (estimated)
- Study completion19 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myeloablative Allogeneic Hematopoietic Cell TransplantationStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- THOR Photomedicine Ltd
- Responsible party
- Principal investigator, Kentaro Ikeda, DDS, MPH, Dana-Farber Cancer Institute
- Investigators
- Kentaro Ikeda, DDS, MPH, Principal investigator, Brigham and Women's HospitalNathaniel S. Treister, DMD, DMSc, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05335434
- Sponsor's protocol ID
- 22-036
- Status last verified
- Dec 2025
- First submitted
- 13 Apr 2022
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center Pilot Study of Intraoral Photobiomodulation Therapy for the Prevention of Oral Mucositis in Patients Undergoing Myeloablative Allogeneic Hematopoietic Cell Transplantation
- ClinicalTrials.gov ID
- NCT05335434
- Acronym / sponsor ID
- 22-036
- Conditions
- Myeloablative Allogeneic Hematopoietic Cell Transplantation, Intraoral Photobiomodulation Therapy, Oral Mucositis, Mucosal Ulcer
- Keywords
- Myeloablative Allogeneic Hematopoietic Cell Transplantation (HCT), Intraoral Photobiomodulation Therapy, Oral Mucositis, Mucosal Ulcer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- THOR Photomedicine Ltd
- Study start
- 10 Jun 2022 (actual)
- Primary completion
- 20 Jun 2026 (estimated)
- Study completion
- 19 Jul 2026 (estimated)
- First posted
- 19 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single center pilot study evaluating intraoral photobiomodulation for the prevention of oral mucositis in patients undergoing myeloablative allogeneic hematopoietic cell transplantation (alloHCT). Patients who are planned for alloHCT will receive daily intraoral photobiomodulation therapy (PBMT) using a novel LED device.
The name of the study device involved in this study is:
- THOR LX2.3 with LED Lollipop
Detailed description
As part of a transplant procedure patients will receive chemotherapy in a conditioning regimen in preparation of alloHCT as well as immunosuppressive medications to help prevent graft-versus-host disease ("GVHD prophylaxis"). Together, these treatments will put patients at risk for developing side effects. A common side effect is oral mucositis (OM), in which mouth sores develop making eating and speaking difficult and painful.
Photobiomodulation therapy (PBMT) is a light-based therapy that reduces inflammation and enhances wound healing. PBMT delivered inside the mouth has been shown to reduce OM in patients undergoing alloHCT.
The name of the study device involved in this study is:
- THOR LX2.3 with LED Lollipop
This research study is a Pilot Study, which is the first time that investigators are examining this LED based intraoral PBMT.
The U.S. Food and Drug Administration (FDA) has not approved PBMT for this specific disease but it has been approved for other uses.
The research study procedures include: screening for eligibility and study treatment including daily PBMT and clinical evaluations.
Participants will receive 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.
It is expected that about 20 people will take part in this research study
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| INTRAORAL PBMT IN PATIENTS UNDERGOING alloHCT | Experimental | Device: THOR LX2.3 with LED LollipopThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Planned to undergo myeloablative allogeneic HCT using FluBu4 conditioning and Tac-Mtx GVHD prophylaxis.
- Age ≥18 years.
- Ability to understand and the willingness to sign a written informed consent document.
Key exclusion criteria (4 listed)
- Participants who have had treatment with intraoral PBMT within four weeks of admission for HSCT.
- Participants who have a history of radiation therapy to the head and neck.
- Participants who have a history of photosensitivity or underlying disease with known photosensitivity.
- Participants who are planned to receive palifermin for OM prevention.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| THOR LX2.3 with LED LollipopThe intraoral PBMT device will be placed inside of the mouth to deliver the therapeutic light. Each treatment is approximately 2-3 minutes in duration. PBMT will be administered daily starting from the start of conditioning through day +20, or discharge if prior to day +20, with 27 consecutive days defined as a maximum PBMT treatment duration | Device | INTRAORAL PBMT IN PATIENTS UNDERGOING alloHCT |
Primary outcome
Duration of severe Oral Mucositis
Time frame: 20 Days
Defined as the total number of days between day 0 and day +20 on which severe (WHO grade 3 or 4) OM was reported
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kentaro Ikeda, DDS, MPH principal investigator
Brigham and Women's Hospital
Nathaniel S. Treister, DMD, DMSc principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing THOR LX2.3 with LED Lollipop in people with Myeloablative Allogeneic Hematopoietic Cell Transplantation and Intraoral Photobiomodulation Therapy, run by Dana-Farber Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kentaro Ikeda, DDS,MPH (617-732-6570, kikeda4@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of severe Oral Mucositis (time frame: 20 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025.