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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02119897
First Posted: April 22, 2014
Last Update Posted: January 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Nathaniel S. Treister, DMD, DMSc, Dana-Farber Cancer Institute
  Purpose
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.

Condition Intervention
Oropharyngeal Mucositis Myeloablative Hematopoietic Cell Transplantation Low Level Light Therapy Device: Low Level Light Therapy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
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

Further study details as provided by Nathaniel S. Treister, DMD, DMSc, Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • The ability to maneuver and provide a new treatment for mucositis using (extraoral) LLLT [ Time Frame: 20 Days ]

    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)


Secondary Outcome Measures:
  • Patient compliance with completing questionnaires [ Time Frame: 2 Years ]
    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.

  • WHO Oral Toxicity Scale/ChIMES Instrument [ Time Frame: 2 Years ]
    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.

  • Toxicity measured using CTC Version [ Time Frame: 2 Years ]
  • Dose-limiting toxicity [ Time Frame: 2 Years ]

Enrollment: 13
Study Start Date: April 2014
Study Completion Date: April 2016
Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: THOR Model LX2M (THOR Photomedicine Ltd, Chesham, UK)

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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02119897


Locations
United States, Massachusetts
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
Principal Investigator: Nathaniel Treister, DMD,DMSc Brigham and Women's Hospital
  More Information

Publications:
Responsible Party: Nathaniel S. Treister, DMD, DMSc, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT02119897     History of Changes
Other Study ID Numbers: 13-611
First Submitted: April 9, 2014
First Posted: April 22, 2014
Last Update Posted: January 26, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Nathaniel S. Treister, DMD, DMSc, Dana-Farber Cancer Institute:
Oropharyngeal Mucositis
Myeloablative Hematopoietic Cell Transplantation
Low Level Light Therapy

Additional relevant MeSH terms:
Mucositis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases