Photobiomodulation for the Prevention of Oral Mucositis (NCT07290413) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Photobiomodulation for the Prevention of Oral Mucositis
United States78 participantsStarted 2025-12-01
Plain-language 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. 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
Who can participate
Age range
4 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Duration of severe oral mucositis according to the World Health Organization Oral Toxicity Score
Timeframe: Oral mucositis is assessed daily from day 0 through day +20