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Search / Trial NCT05335434

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

Launched by DANA-FARBER CANCER INSTITUTE · Apr 13, 2022

Trial Information

Current as of June 27, 2025

Recruiting

Keywords

Myeloablative Allogeneic Hematopoietic Cell Transplantation (Hct) Intraoral Photobiomodulation Therapy Oral Mucositis Mucosal Ulcer

ClinConnect Summary

This clinical trial is looking at a new way to help prevent a painful condition called oral mucositis in patients who are receiving a type of cancer treatment known as hematopoietic cell transplantation. Oral mucositis can cause painful sores in the mouth, which can make it hard to eat and drink. In this study, patients who are scheduled for this treatment will receive daily sessions of a therapy called photobiomodulation using a special LED device, which is designed to help keep their mouths healthy during treatment.

To participate in this trial, patients need to be at least 18 years old and planned for a specific type of transplant. They also need to be able to understand the study and agree to participate by signing a consent form. However, some people may not be eligible if they have had certain previous treatments or conditions that could interfere with the study. If a patient takes part, they can expect to use the LED device daily, which is a simple and non-invasive way to help protect their mouth during a challenging time.

Gender

ALL

Eligibility 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.

About Dana Farber Cancer Institute

The Dana-Farber Cancer Institute is a premier cancer research and treatment institution located in Boston, Massachusetts. Renowned for its commitment to advancing cancer care through innovative research, the institute integrates cutting-edge clinical trials with a multidisciplinary approach to patient care. With a focus on translating scientific discoveries into effective therapies, Dana-Farber collaborates with a network of leading researchers and healthcare professionals to improve outcomes for patients with cancer. The institute’s dedication to education, advocacy, and community engagement further underscores its mission to eradicate cancer and enhance the quality of life for those affected by the disease.

Locations

Boston, Massachusetts, United States

Patients applied

0 patients applied

Trial Officials

Kentaro Ikeda, DDS, MPH

Principal Investigator

Brigham and Women's Hospital

Nathaniel S. Treister, DMD, DMSc

Principal Investigator

Brigham and Women's Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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