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ACTIVE NOT RECRUITING
NCT07290413
PHASE2

Photobiomodulation for the Prevention of Oral Mucositis

Sponsor: Brigham and Women's Hospital

View on ClinicalTrials.gov

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

Official title: A Phase 2 Randomized Trial of Intraoral, Extraoral, and Combined Intraoral/Extraoral Photobiomodulation for the Prevention of Oral Mucositis in Patients Undergoing Myeloablative Allogeneic Hematopoietic Cell Transplantation

Key Details

Gender

All

Age Range

4 Years - Any

Study Type

INTERVENTIONAL

Enrollment

78

Start Date

2025-12-01

Completion Date

2027-05

Last Updated

2025-12-18

Healthy Volunteers

No

Conditions

Interventions

DEVICE

Photobiomodulation - INTRAORAL

Participants will receive intraoral photobiomodulation

DEVICE

Photobiomodulation - EXTRAORAL

Participants will receive extraoral photobiomodulation

DEVICE

Photobiomodulation - INTRAORAL and EXTRAORAL

Participants will receive intraoral and extraoral photobiomodulation

Locations (1)

Dana-Farber Cancer Institute

Boston, Massachusetts, United States