Feasibility Study of Low Level Light Therapy for Prevention of Oropharyngeal Mucositis in Pediatric Transplants Patients

Feasibility Study Evaluating Extraorally Delivered Low Level Light Therapy (LLLT) for the Prevention of Oropharyngeal Mucositis in Pediatric Patients Undergoing Myeloablative Hematopoietic Cell Transplantation

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.

Study Overview

• Status: Completed
• Conditions: Low Level Light Therapy; Oropharyngeal Mucositis; Myeloablative Hematopoietic Cell Transplantation
• Intervention / Treatment: Device: Low Level Light Therapy

Detailed 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

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Dana Farber Cancer Institute
    • Boston, Massachusetts, United States, 02115
      • Boston Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 25 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Low Level Light Therapy (LLLT); 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.

Device: Low Level Light Therapy; Other Names: THOR Model LX2M (THOR Photomedicine Ltd, Chesham, UK)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The ability to maneuver and provide a new treatment for mucositis using (extraoral) LLLT	Several measures will be collected to evaluate the overall feasibility of providing daily extraoral LLLT for children undergoing HSCT including: Accessibility and maneuverability of the LLLT device (transportation from storage site to hospital room, device weight); Administration of LLLT (device settings, positioning of device, delivery of therapy); Patient tolerability (level of comfort during treatments, compliance with daily therapy; Proportion of days with therapy administered, as evidence by data submitted (goal is ≥75%); Ability to enroll at least 5 patients within the first 3 months (this pertains to the feasibility of study conduct, and not to the feasibility of the therapeutic approach)	20 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient compliance with completing questionnaires	To address secondary the investigators, will calculate the following proportion: (number of times patients refused to complete one or both questionnaires) / (number of questionnaire completion timepoints), and place a 95% confidence interval on the proportion.	2 Years
WHO Oral Toxicity Scale/ChIMES Instrument	To address secondary aim, the investigator, will analyze the data from the WHO Oral Toxicity Scale and the ChIMES instrument using the analytic methods specifically prescribed for these standardized instruments.	2 Years
Toxicity measured using CTC Version		2 Years
Dose-limiting toxicity		2 Years

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute
• Investigators: Principal Investigator: Nathaniel Treister, DMD,DMSc, Brigham and Women's Hospital

Publications and helpful links

General Publications

• Treister NS, London WB, Guo D, Malsch M, Verrill K, Brewer J, Margossian S, Duncan C. A Feasibility Study Evaluating Extraoral Photobiomodulation Therapy for Prevention of Mucositis in Pediatric Hematopoietic Cell Transplantation. Photomed Laser Surg. 2016 Apr;34(4):178-84. doi: 10.1089/pho.2015.4021. Epub 2016 Mar 16.

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: April 9, 2014
• First Submitted That Met QC Criteria: April 18, 2014
• First Posted (Estimate): April 22, 2014

Study Record Updates

• Last Update Posted (Estimate): January 26, 2017
• Last Update Submitted That Met QC Criteria: January 25, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Low Level Light Therapy; Oropharyngeal Mucositis; Myeloablative Hematopoietic Cell Transplantation
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Stomatognathic Diseases; Mouth Diseases; Mucositis
• Other Study ID Numbers: 13-611

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO