Using light therapy to prevent mouth sores in patients getting stem cell transplants
A Single Center Pilot Study of Intraoral Photobiomodulation Therapy for the Prevention of Oral Mucositis in Patients Undergoing Myeloablative Allogeneic Hematopoietic Cell Transplantation
This study is testing if a special light therapy can help prevent mouth sores in patients getting stem cell transplants.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Dana-Farber Cancer Institute Academic / other |
| Drugs / interventions | radiation, chemotherapy |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT05335434 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are planned to undergo myeloablative allogeneic HCT with specific conditioning and prophylaxis regimens.
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.
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 performed: While this specific application of PBMT is novel, similar approaches have shown promise in reducing oral mucositis in other patient populations.
Eligibility criteria
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 this trial is running
Boston, Massachusetts
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.