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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Nathaniel S. Treister, DMD, DMSc, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT02119897
First received: April 9, 2014
Last updated: October 14, 2014
Last verified: October 2014
  Purpose

In this research study, the investigators are assessing the feasibility of providing extraorally delivered low level light therapy LLLT for the prevention of oropharyngeal mucositis OM in children undergoing myeloablative hematopoietic cell transplantation 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: Open Label
Primary Purpose: Prevention
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 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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
  • Dose-limiting toxicity [ Time Frame: 2 Years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 12
Study Start Date: April 2014
Estimated Study Completion Date: May 2019
Estimated Primary Completion Date: September 2017 (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: First day of conditioning through Day +20
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 evaluating the feasibility of extraorally delivered low level light therapy (LLLT) for the prevention of oropharyngeal mucositis (OM) in pediatric patients undergoing myeloablative hematopoietic cell transplantation (HCT). 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. Subjects 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. There will be no further treatments or assessments beyond day +20. The study will enroll a total of twelve evaluable patients

  Eligibility

Ages Eligible for Study:   4 Years to 25 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: April 9, 2014
Last Updated: October 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:
Oropharyngeal Mucositis
Myeloablative Hematopoietic Cell Transplantation
Low Level Light Therapy

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

ClinicalTrials.gov processed this record on November 27, 2014