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

Oral mucositis (OM) is a painful and potentially debilitating acute toxicity that frequently affects children undergoing hematopoietic cell transplantation (HCT). As a result of intensive conditioning with chemotherapy with or without total body irradiation, and in the case of allogeneic HCT, graft-versus-host disease (GVHD) prophylaxis, patients are at risk for developing diffuse ulcerations of the oral and esophageal mucosa that result in pain and suffering, increased utilization of opioid analgesics, and the need for intravenous or total parenteral nutritional support. Patients universally report OM as being the worst aspect of the HCT experience.A novel approach has been the use of larger light-emitting diode arrays to treat the at risk tissues from an extraoral approach, enabling exposure of the oral, oropharyngeal, and esophageal mucosa while avoiding the need for intraoral manipulation, and requiring only minimal patient cooperation. In this research study, the investigators are assessing the feasibility of providing extraorally delivered low level light therapy (LLLT) for the prevention of OM in children undergoing myeloablative HCT.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Intervention model single group assignment
Primary purpose prevention
Masking open label
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: 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. Evaluation: Participants 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.
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

All 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. The study is targeted to enroll twelve evaluable patients OBJECTIVES: Primary - Determine the feasibility of providing extraoral LLLT for prevention of OM in pediatric patients undergoing HCT Secondary - Determine the feasibility of collecting data using the WHO Oral Toxicity Scale and ChIMES in pediatric patients undergoing myeloablative HCT who are treated with extraoral LLLT for prevention of OM - Evaluate the safety and tolerability of extraoral LLLT for prevention of OM in pediatric patients undergoing myeloablative HCT
Trial information was received from ClinicalTrials.gov and was last updated in January 2017.
Information provided to ClinicalTrials.gov by Dana-Farber Cancer Institute.