Overview

This trial has been completed.

Conditions oropharyngeal mucositis, myeloablative hematopoietic cell transplantation, low level light therapy
Treatment low level light therapy
Sponsor Dana-Farber Cancer Institute
Start date April 2014
End date November 2015
Trial size 13 participants
Trial identifier NCT02119897, 13-611

Summary

In this research study, the investigators are assessing the feasibility of providing extraorally delivered low level light therapy LLLT for the prevention of oropharyngeal mucositis OM in children undergoing myeloablative hematopoietic cell transplantation HCT.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
LLLT: The LLLT device will be positioned next to the face and neck for a total of 6 exposures: Right face, Midline face, Left face, Left neck, Midline neck, Right neck Dose per anatomic site 50mW/cm2, 60 sec = 3.0J/cm2 Route: Extraoral Total Treatment Time (all sites) 6 min Schedule: First day of conditioning through Day +20
low level light therapy THOR Model LX2M (THOR Photomedicine Ltd, Chesham, UK)

Primary Outcomes

Measure
The ability to maneuver and provide a new treatment for mucositis using (extraoral) LLLT
time frame: 20 Days

Secondary Outcomes

Measure
Patient compliance with completing questionnaires
time frame: 2 Years
WHO Oral Toxicity Scale/ChIMES Instrument
time frame: 2 Years
Toxicity measured using CTC Version
time frame: 2 Years
Dose-limiting toxicity
time frame: 2 Years

Eligibility Criteria

Male or female participants from 4 years up to 25 years old.

Inclusion Criteria: - Scheduled to undergo myeloablative conditioning followed by autologous or allogeneic hematopoietic cell transplantation at Boston Children's Hospital. - 4 years of age to 25 years of age. - WHO Oral Toxicity score of 0 at baseline evaluation (first day of conditioning). - Ability to understand and the willingness to sign a written informed consent document (for patients under the age of 18 this applies to parent/guardian) - Ability to understand and/or the willingness of their parent or legally authorized representative to sign a written informed consent document. Exclusion Criteria: - Treatment with oral LLLT within 4 weeks of HCT. - Participants may not be receiving any other agents intended for the prevention/management of mucositis (including palifermin and ice chips/cryotherapy). - WHO ≥1 at baseline evaluation.

Additional Information

Official title Feasibility Study Evaluating Extraorally Delivered Low Level Light Therapy (LLLT) for the Prevention of Oropharyngeal Mucositis in Pediatric Patients Undergoing Myeloablative Hematopoietic Cell Transplantation
Principal investigator Nathaniel Treister, DMD,DMSc
Description This is an open label, single treatment arm clinical pilot study evaluating the feasibility of extraorally delivered low level light therapy (LLLT) for the prevention of oropharyngeal mucositis (OM) in pediatric patients undergoing myeloablative hematopoietic cell transplantation (HCT). Participants will be treated daily (including weekends and holidays) beginning on the first day of HCT conditioning and continuing through day +20 or hospital discharge if prior to day +20. Subjects will undergo formal mucositis and toxicity assessments at baseline and daily from day -1 through day +20, with a final assessment on the last day of treatment. There will be no further treatments or assessments beyond day +20. The study will enroll a total of twelve evaluable patients
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Dana-Farber Cancer Institute.