Photobiomodulation for the Prevention of Oral Mucositis
NCT ID: NCT07290413
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
78 participants
INTERVENTIONAL
2025-12-01
2027-05-31
Brief Summary
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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
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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
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Intraoral photobiomodulation
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.
Photobiomodulation - INTRAORAL
Participants will receive intraoral photobiomodulation
Extraoral photobiomodulation
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.
Photobiomodulation - EXTRAORAL
Participants will receive extraoral photobiomodulation
Combined intraoral and extraoral photobiomodulation
Participants in this arm will receive both intraoral and extraoral photobiomodulation.
Photobiomodulation - INTRAORAL and EXTRAORAL
Participants will receive intraoral and extraoral photobiomodulation
Interventions
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Photobiomodulation - INTRAORAL
Participants will receive intraoral photobiomodulation
Photobiomodulation - EXTRAORAL
Participants will receive extraoral photobiomodulation
Photobiomodulation - INTRAORAL and EXTRAORAL
Participants will receive intraoral and extraoral photobiomodulation
Eligibility Criteria
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Inclusion Criteria
* Age ≥4 years
* Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria
* 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.
4 Years
ALL
No
Sponsors
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Brigham and Women's Hospital
OTHER
Responsible Party
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Nathaniel Simon Treister
Associate Surgeon
Locations
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Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Countries
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Other Identifiers
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25-137
Identifier Type: -
Identifier Source: org_study_id