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

Low Level Light Therapy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02119897
• Other study ID #: 13-611
• Status: Completed
• Phase: N/A
• First received: April 9, 2014
• Last updated: January 25, 2017
• Start date: April 2014
• Est. completion date: April 2016

Study information

• Verified date: January 2017
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: April 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Device:
• Low Level Light Therapy

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts
United States	Dana Farber Cancer Institute	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute

Country where clinical trial is conducted

United States, 

References & 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. 201 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Toxicity measured using CTC Version		2 Years
Secondary	Dose-limiting toxicity		2 Years