RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

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

Quick Facts

Study Start:2022-06-10
Study Completion:2026-07-19
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05335434

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Planned to undergo myeloablative allogeneic HCT using FluBu4 conditioning and Tac-Mtx GVHD prophylaxis.
  2. * Age ≥18 years.
  3. * Ability to understand and the willingness to sign a written informed consent document.
  1. * Participants who have had treatment with intraoral PBMT within four weeks of admission for HSCT.
  2. * Participants who have a history of radiation therapy to the head and neck.
  3. * Participants who have a history of photosensitivity or underlying disease with known photosensitivity.
  4. * Participants who are planned to receive palifermin for OM prevention.

Contacts and Locations

Study Contact

Kentaro Ikeda, DDS,MPH
CONTACT
617-732-6570
kikeda4@bwh.harvard.edu

Principal Investigator

Kentaro Ikeda, DDS, MPH
PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital
Nathaniel S. Treister, DMD, DMSc
PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital

Study Locations (Sites)

Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States

Collaborators and Investigators

Sponsor: Dana-Farber Cancer Institute

  • Kentaro Ikeda, DDS, MPH, PRINCIPAL_INVESTIGATOR, Brigham and Women's Hospital
  • Nathaniel S. Treister, DMD, DMSc, PRINCIPAL_INVESTIGATOR, Brigham and Women's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-06-10
Study Completion Date2026-07-19

Study Record Updates

Study Start Date2022-06-10
Study Completion Date2026-07-19

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Myeloablative Allogeneic Hematopoietic Cell Transplantation
  • Intraoral Photobiomodulation Therapy
  • Oral Mucositis
  • Mucosal Ulcer