Using light therapy to prevent mouth sores in patients getting stem cell transplants
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
Run by Dana-Farber Cancer Institute · NCT05335434 · Data updated 2026-11-12
This study is testing if a special light therapy can help prevent mouth sores in patients getting stem cell transplants.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Dana-Farber Cancer Institute Academic / other |
| Drugs / interventions | radiation, chemotherapy |
| Locations | 1 site (Boston, Massachusetts) |
| Status | Recruiting |
| Started | June 10, 2022 |
| Main results expected | June 20, 2026 |
| Study ends | July 19, 2026 |
| Registry record updated | December 15, 2025 |
| Trial ID | NCT05335434 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older who are planned to undergo myeloablative allogeneic HCT with specific conditioning and prophylaxis regimens.
✕Probably not a fit
Patients who have received intraoral PBMT recently, have a history of radiation therapy to the head and neck, or have known photosensitivity conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This pilot study evaluates the effectiveness of intraoral photobiomodulation therapy (PBMT) in preventing oral mucositis in patients undergoing myeloablative allogeneic hematopoietic cell transplantation (alloHCT). Participants will receive daily PBMT using a novel LED device, the THOR LX2.3 with LED Lollipop, starting from the conditioning chemotherapy phase until day +20 or discharge. The study aims to assess the impact of this light-based therapy on reducing inflammation and enhancing wound healing in the oral cavity. Approximately 20 patients will be enrolled in this single-center study at Brigham and Women's Hospital.
Why it matters
Potential benefit: If successful, this therapy could significantly reduce the incidence and severity of oral mucositis, improving the quality of life for patients undergoing stem cell transplants.
How similar studies have gone: While this specific application of PBMT is novel, similar approaches have shown promise in reducing oral mucositis in other patient populations.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Where it's running
-
Brigham and Women's Hospital
Boston, Massachusetts, United States Recruiting
Study contacts
- Principal investigator: Kentaro Ikeda, DDS, MPH — Brigham and Women's Hospital
- Study coordinator: Kentaro Ikeda, DDS,MPH
- Email: kikeda4@bwh.harvard.edu
- Phone: 617-732-6570
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Copaiba Mouthwash with Low-Level Laser Therapy to Prevent Mouth Sores After Stem Cell Transplant
This phase 2 trial tests whether a copaíba-based mouthwash, used four times daily, can help prevent oral mucositis in patients undergoing autologous hematopoietic stem cell transplantation.
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Chlorophyllin to reduce mouth sores before allogeneic stem cell transplant
This phase II study tests whether taking chlorophyllin by mouth can lower the chances and severity of mouth ulcers in patients aged 12–65 undergoing radiation-based conditioning before a first allogeneic stem cell transplant.
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BupiZenge vs Lidocaine for mouth pain from oral mucositis in head and neck cancer
A phase 3 trial tests whether the BupiZenge lozenge provides better pain relief than lidocaine for mouth sores caused by radiation in head and neck cancer patients.
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Ozone gas plus biomimetic toothpaste and mouthwash to treat cancer therapy mouth sores
This trial will test whether adding a biomimetic toothpaste and mouthwash to ozone gas therapy helps adults with chemo- or radiotherapy-induced mouth sores heal faster and have less pain.
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High-level laser therapy for oral mucositis in children receiving hematopoietic stem cell transplant
This trial tests whether high-level laser therapy can reduce the pain and severity of oral mucositis in children undergoing hematopoietic stem cell (bone marrow) transplantation.
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Amimestrocel infusion to prevent severe mouth sores after allogeneic stem cell transplant
This study will try a single IV infusion of Amimestrocel in adults receiving myeloablative allogeneic stem cell transplants with TBI or melphalan to see if it prevents severe mouth sores.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.