Clinical trial Recruiting at 1 site Interventional Ages 18 and up

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 typeInterventional
Ages18 Years and up
SexAll
Enrollment20 (estimated)
SponsorDana-Farber Cancer Institute
Academic / other
Drugs / interventionsradiation, chemotherapy
Locations1 site (Boston, Massachusetts)
StatusRecruiting
StartedJune 10, 2022
Main results expectedJune 20, 2026
Study endsJuly 19, 2026
Registry record updatedDecember 15, 2025
Trial IDNCT05335434 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.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.