Oral MucositisPhase 2NCT07290413
Photobiomodulation for the Prevention of Oral Mucositis
A Phase 2 study testing Photobiomodulation - INTRAORAL, Photobiomodulation - EXTRAORAL and Photobiomodulation - INTRAORAL and EXTRAORAL in people with Oral Mucositis, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if photobiomodulation works to prevent severe oral mucositis in patients who are undergoing allogeneic hematopoietic cell transplantation. Read more about this study
- Who is it for?
- Ages 4 years and older
- Conditions the study is for
- Oral Mucositis
- What is being tested?
- Photobiomodulation - INTRAORAL, Photobiomodulation - EXTRAORAL and Photobiomodulation - INTRAORAL and EXTRAORAL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2025to May 2027
- Phase
- Phase 2
- 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 4 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Planned to undergo myeloablative allogeneic HCT (with one of the following regimens): FluBu4, FluMel, or CyTBI conditioning and Tac-Mtx GVHD prophylaxis
- Age ≥4 years
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Participants who have had treatment with oral 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 (keratinocyte growth factor) for OM prevention.
- Participants who have facial hair and unwilling to shave.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: A Phase 2 Randomized Trial of Intraoral, Extraoral, and Combined Intraoral/Extraoral Photobiomodulation for the Prevention of Oral Mucositis in Patients Undergoing Myeloablative Allogeneic Hematopoietic Cell Transplantation
The goal of this clinical trial is to learn if photobiomodulation works to prevent severe oral mucositis in patients who are undergoing allogeneic hematopoietic cell transplantation. The main questions it aims to answer are:
Does 1) intraoral , 2) extraoral, or 3) combined intraoral/extraoral photobiomodulation have optimal prevention/therapeutic effect in prevention of oral mucositis in patients undergoing myeloablative allogeneic hematopoietic stem cell transplantation (alloHSCT).
Read more
Participants will:
Be randomized to one of the three treatment arms Receive daily photobiomodulation therapy (from beginning of transplant conditioning through Day +20 after transplantation) Be evaluated for oral mucositis and symptoms daily Visit the clinic once every 2 weeks for checkups and tests Keep a diary of their symptoms and the number of times they use a rescue inhaler
Read the detailed description
Patients who are planned for alloHSCT will be randomized 1:1:1 to one of the 3 treatment arms, stratified by age (<18, ≥ 18years). This is a phase 2 randomized trial to identify which of the three photobiomodulation therapy (PBMT) devices, 1) intraoral , 2) extraoral, and 3) combined intraoral/extraoral, has optimal prevention/therapeutic effect in prevention of oral mucositis in patients undergoing myeloablative allogeneic hematopoietic stem cell transplantation (alloHSCT). The study will be conducted in parallel, in a quasi-multi-center manner at three other alloHSCT centers (AC Camargo, SP, Brazil; Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil; Cincinnati Children's Hospital Medical Center; in addition to DFCI/BWH).
Participants will be evaluated daily according to the validated WHO Oral Toxicity Scale by trained and calibrated investigators. Within each arm, a Simon's 2 stage design will be applied in an intention to treat analysis of the proportion of patients who have <5 days of WHO grade ≥ 3 OM, to eliminate arms with insufficient evidence of efficacy. The remaining arms will be analyzed in a selection design (pick the winner) to determine the probability that the arm selected for a future phase 3 trial is either superior to, or at worst, more or less equivalent to, other arm(s). The study will enroll up to 96 patients with up to 26 patients per treatment arm. The accrual rate at DFCI is anticipated to be 2 patients/month, or 24 patients per year. The same accrual rate is anticipated at each of the other three study sites. Therefore, the total accrual of 78 patients can be achieved within 1 year.
The primary endpoint, duration of severe OM, is defined in section 11.1 as the total number of days between day 0 and day +20 on which severe (WHO grade 3 or 4) OM was reported. A conservative approach to missing data will be taken: Any day on which the grading of mucositis is missing will be counted as a day with WHO grade ≥3 OM. Each patient will be classified as either a success or a failure. "Success" will be defined as a patient who has a duration of WHO grade ≥3 OM <5 days; a patient with ≥5 days will be classified as a "failure" (i.e., a binary endpoint).
The secondary endpoints that will be subjectively considered in making the final selection of the winning arm are:
- Adverse events attributed to PBMT administration;
- Patient acceptability of the PBMT administration;
- Operator acceptability of the PBMT administration;
- Duration of time to complete PBMT administration;
- Duration of hospital stay; and,
- Need to initiate parenteral nutrition.
- Conditions
- Oral Mucositis
- Being tested
- Photobiomodulation - INTRAORAL, Photobiomodulation - EXTRAORAL, Photobiomodulation - INTRAORAL and EXTRAORAL
- Medical subject headings
- Stomatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photobiomodulation - INTRAORALDevice
Participants will receive intraoral photobiomodulation
Photobiomodulation - EXTRAORALDevice
Participants will receive extraoral photobiomodulation
Photobiomodulation - INTRAORAL and EXTRAORALDevice
Participants will receive intraoral and extraoral photobiomodulation
| Study group | Role | What they receive |
|---|---|---|
| Intraoral photobiomodulation | Experimental | 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. Receives: Device: Photobiomodulation - INTRAORAL |
| Extraoral photobiomodulation | Experimental | 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. Receives: Device: Photobiomodulation - EXTRAORAL |
| Combined intraoral and extraoral photobiomodulation | Experimental | Participants in this arm will receive both intraoral and extraoral photobiomodulation. Receives: Device: Photobiomodulation - INTRAORAL and EXTRAORAL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of severe oral mucositis according to the World Health Organization Oral Toxicity Score
WHO Score (0-4, "severe" defined as grades 3 and 4)
Measured: Oral mucositis is assessed daily from day 0 through day +20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start1 Dec 2025
- Primary completionDec 2026 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral MucositisStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nathaniel Simon Treister, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07290413
- Sponsor's protocol ID
- 25-137
- Status last verified
- Dec 2025
- First submitted
- 16 Dec 2025
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Randomized Trial of Intraoral, Extraoral, and Combined Intraoral/Extraoral Photobiomodulation for the Prevention of Oral Mucositis in Patients Undergoing Myeloablative Allogeneic Hematopoietic Cell Transplantation
- ClinicalTrials.gov ID
- NCT07290413
- Acronym / sponsor ID
- 25-137
- Conditions
- Oral Mucositis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 18 Dec 2025 (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.
The goal of this clinical trial is to learn if photobiomodulation works to prevent severe oral mucositis in patients who are undergoing allogeneic hematopoietic cell transplantation. The main questions it aims to answer are:
Does 1) intraoral , 2) extraoral, or 3) combined intraoral/extraoral photobiomodulation have optimal prevention/therapeutic effect in prevention of oral mucositis in patients undergoing myeloablative allogeneic hematopoietic stem cell transplantation (alloHSCT).
Participants will:
Be randomized to one of the three treatment arms Receive daily photobiomodulation therapy (from beginning of transplant conditioning through Day +20 after transplantation) Be evaluated for oral mucositis and symptoms daily Visit the clinic once every 2 weeks for checkups and tests Keep a diary of their symptoms and the number of times they use a rescue inhaler
Detailed description
Patients who are planned for alloHSCT will be randomized 1:1:1 to one of the 3 treatment arms, stratified by age (<18, ≥ 18years). This is a phase 2 randomized trial to identify which of the three photobiomodulation therapy (PBMT) devices, 1) intraoral , 2) extraoral, and 3) combined intraoral/extraoral, has optimal prevention/therapeutic effect in prevention of oral mucositis in patients undergoing myeloablative allogeneic hematopoietic stem cell transplantation (alloHSCT). The study will be conducted in parallel, in a quasi-multi-center manner at three other alloHSCT centers (AC Camargo, SP, Brazil; Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil; Cincinnati Children's Hospital Medical Center; in addition to DFCI/BWH).
Participants will be evaluated daily according to the validated WHO Oral Toxicity Scale by trained and calibrated investigators. Within each arm, a Simon's 2 stage design will be applied in an intention to treat analysis of the proportion of patients who have <5 days of WHO grade ≥ 3 OM, to eliminate arms with insufficient evidence of efficacy. The remaining arms will be analyzed in a selection design (pick the winner) to determine the probability that the arm selected for a future phase 3 trial is either superior to, or at worst, more or less equivalent to, other arm(s). The study will enroll up to 96 patients with up to 26 patients per treatment arm. The accrual rate at DFCI is anticipated to be 2 patients/month, or 24 patients per year. The same accrual rate is anticipated at each of the other three study sites. Therefore, the total accrual of 78 patients can be achieved within 1 year.
The primary endpoint, duration of severe OM, is defined in section 11.1 as the total number of days between day 0 and day +20 on which severe (WHO grade 3 or 4) OM was reported. A conservative approach to missing data will be taken: Any day on which the grading of mucositis is missing will be counted as a day with WHO grade ≥3 OM. Each patient will be classified as either a success or a failure. "Success" will be defined as a patient who has a duration of WHO grade ≥3 OM <5 days; a patient with ≥5 days will be classified as a "failure" (i.e., a binary endpoint).
The secondary endpoints that will be subjectively considered in making the final selection of the winning arm are:
- Adverse events attributed to PBMT administration;
- Patient acceptability of the PBMT administration;
- Operator acceptability of the PBMT administration;
- Duration of time to complete PBMT administration;
- Duration of hospital stay; and,
- Need to initiate parenteral nutrition.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intraoral photobiomodulation | Experimental | Device: Photobiomodulation - INTRAORALIntraoral 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 photobiomodulation | Experimental | Device: Photobiomodulation - EXTRAORALExtraoral 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. |
| Combined intraoral and extraoral photobiomodulation | Experimental | Device: Photobiomodulation - INTRAORAL and EXTRAORALParticipants in this arm will receive both intraoral and extraoral photobiomodulation. |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Planned to undergo myeloablative allogeneic HCT (with one of the following regimens): FluBu4, FluMel, or CyTBI conditioning and Tac-Mtx GVHD prophylaxis
- Age ≥4 years
- Ability to understand and the willingness to sign a written informed consent document.
Key exclusion criteria (5 listed)
- Participants who have had treatment with oral 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 (keratinocyte growth factor) for OM prevention.
- Participants who have facial hair and unwilling to shave.
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 |
|---|---|---|
| Photobiomodulation - INTRAORALParticipants will receive intraoral photobiomodulation | Device | Intraoral photobiomodulation |
| Photobiomodulation - EXTRAORALParticipants will receive extraoral photobiomodulation | Device | Extraoral photobiomodulation |
| Photobiomodulation - INTRAORAL and EXTRAORALParticipants will receive intraoral and extraoral photobiomodulation | Device | Combined intraoral and extraoral photobiomodulation |
Primary outcome
Duration of severe oral mucositis according to the World Health Organization Oral Toxicity Score
Time frame: Oral mucositis is assessed daily from day 0 through day +20
WHO Score (0-4, "severe" defined as grades 3 and 4)
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 18 Dec 2025.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Photobiomodulation - INTRAORAL, Photobiomodulation - EXTRAORAL and Photobiomodulation - INTRAORAL and EXTRAORAL in people with Oral Mucositis, run by Brigham and Women's Hospital 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 5 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: under way, not looking for participants, as of the sponsor's last update on 18 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of severe oral mucositis according to the World Health Organization Oral Toxicity Score (time frame: Oral mucositis is assessed daily from day 0 through day +20). 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 18 Dec 2025.