RecruitingNot ApplicableNCT05335434

Intraoral Photobiomodulation Therapy to Prevent Oral Mucositis in Patients Undergoing Hematopoietic Cell Transplantation

A Single Center Pilot Study of Intraoral Photobiomodulation Therapy for the Prevention of Oral Mucositis in Patients Undergoing Myeloablative Allogeneic Hematopoietic Cell Transplantation


Sponsor

Dana-Farber Cancer Institute

Enrollment

20 participants

Start Date

Jun 10, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This is a single center pilot study evaluating intraoral photobiomodulation for the prevention of oral mucositis in patients undergoing myeloablative allogeneic hematopoietic cell transplantation (alloHCT). Patients who are planned for alloHCT will receive daily intraoral photobiomodulation therapy (PBMT) using a novel LED device. The name of the study device involved in this study is: \- THOR LX2.3 with LED Lollipop


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether photobiomodulation therapy (a specialized light treatment applied inside the mouth) can prevent oral mucositis — painful sores in the mouth — that commonly develop in patients receiving intensive chemotherapy before a stem cell transplant. You may be eligible if: - You are 18 years old or older - You are planned to undergo myeloablative allogeneic hematopoietic cell transplantation (HCT) using FluBu4 conditioning with Tac-Mtx GVHD prevention - You are able to understand and sign informed consent You may NOT be eligible if: - You received intraoral photobiomodulation therapy within the past 4 weeks before your transplant admission - You have a history of radiation therapy to the head or neck - You have a history of photosensitivity or a disease causing photosensitivity - You are planned to receive palifermin for mouth sore prevention Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICETHOR LX2.3 with LED Lollipop

The intraoral PBMT device will be placed inside of the mouth to deliver the therapeutic light. Each treatment is approximately 2-3 minutes in duration. PBMT will be administered daily starting from the start of conditioning through day +20, or discharge if prior to day +20, with 27 consecutive days defined as a maximum PBMT treatment duration


Locations(1)

Brigham and Women's Hospital

Boston, Massachusetts, United States

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NCT05335434


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