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NCT Number: NCT02119897

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

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.

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Key information

Conditions

Oropharyngeal Mucositis Low Level Light Therapy Myeloablative Hematopoietic Cell Transplantation

Age range

4 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston Children's Hospital, Boston, Massachusetts, United States

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Low Level Light Therapy

Device

Other names: THOR Model LX2M (THOR Photomedicine Ltd, Chesham, UK)

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

  3. Toxicity measured using CTC Version

    Time frame: 2 Years

  4. Dose-limiting toxicity

    Time frame: 2 Years

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Apr 22, 2014
Registry last updated
Jan 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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