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

NCT02119897 | Completed DMC

• 1 other identifier: 13-611
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Oropharyngeal Mucositis; Myeloablative Hematopoietic Cell Transplantation; Low Level Light Therapy

Keywords

Oropharyngeal Mucositis; Myeloablative Hematopoietic Cell Transplantation; Low Level Light Therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Patient compliance with completing questionnaires

  2 Years

• WHO Oral Toxicity Scale/ChIMES Instrument

  2 Years

• Toxicity measured using CTC Version

  2 Years

• Dose-limiting toxicity

  2 Years

Study Arms (1)

Low Level Light Therapy (LLLT)

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.

Device: Low Level Light Therapy

Interventions

Low Level Light Therapy DEVICE

Also known as: THOR Model LX2M (THOR Photomedicine Ltd, Chesham, UK)

Low Level Light Therapy (LLLT)

Eligibility Criteria

• Age: 4 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Scheduled to undergo myeloablative conditioning followed by autologous or allogeneic hematopoietic cell transplantation at Boston Children's Hospital.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead

Study Sites (2)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

• 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.

  PMID: 26982624 RESULT

MeSH Terms

Interventions

Low-Level Light Therapy

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Nathaniel Treister, DMD,DMSc

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 9, 2014
• First Posted: April 22, 2014
• Study Start: April 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: April 1, 2016
• Last Updated: January 26, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)