RECRUITING

Tacrolimus Toothpaste for Management of Oral Chronic Graft vs. Host Disease (cGVHD)

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 study aims to investigate the use of a novel formulation of tacrolimus, as a toothpaste, in a population of patients with oral chronic graft vs. host disease (cGVHD) as an adjunctive therapy in addition to standard-of-care systemic therapy. The investigators plan to summarize our findings to add to the current body of literature regarding managing cGVHD, specifically those with oral involvement. Additionally, establishing effective topical application of tacrolimus in the oral cavity will allow for future prospective studies comparing outcomes for these patients with a more traditional standard of care.

Official Title

Prospective Study of Tacrolimus Toothpaste for Management of Oral Chronic Graft vs. Host Disease (cGVHD) in Stem Cell Transplant Patients

Quick Facts

Study Start:2024-09-17
Study Completion:2026-09-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06638879

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:1 Year to 40 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients with oral chronic graft vs. host disease (cGVHD)
  2. * Stable immune suppression within two weeks of enrollment
  3. * Ages \> 1 year and \< 40 years
  1. * Clinically confirmed or suspected herpes simplex virus (HSV) stomatitis
  2. * A recent (within 2 weeks of enrollment) escalation in immune suppression or change in systemic immune suppression of ongoing chronic graft vs. host disease (cGVHD)

Contacts and Locations

Study Contact

Allison Bartlett, MD
CONTACT
(513) 803-0528
Allison.Bartlett@cchmc.org

Principal Investigator

Allison Bartlett, MD
PRINCIPAL_INVESTIGATOR
Children's Hospital Medical Center, Cincinnati

Study Locations (Sites)

Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
United States

Collaborators and Investigators

Sponsor: Children's Hospital Medical Center, Cincinnati

  • Allison Bartlett, MD, PRINCIPAL_INVESTIGATOR, Children's Hospital Medical Center, Cincinnati

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 Date2024-09-17
Study Completion Date2026-09-01

Study Record Updates

Study Start Date2024-09-17
Study Completion Date2026-09-01

Terms related to this study

Additional Relevant MeSH Terms

  • Chronic Graft Versus Host Disease Oral