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Prevention of Oral Mucositis Using Photobiomodulation Therapy

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ClinicalTrials.gov Identifier: NCT04227340
Recruitment Status : Completed
First Posted : January 13, 2020
Last Update Posted : August 11, 2021
Sponsor:
Collaborator:
Association of Pediatric Hematology Oncology Nurses
Information provided by (Responsible Party):
St. Jude Children's Research Hospital

Tracking Information
First Submitted Date  ICMJE January 8, 2020
First Posted Date  ICMJE January 13, 2020
Last Update Posted Date August 11, 2021
Actual Study Start Date  ICMJE February 4, 2020
Actual Primary Completion Date May 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 10, 2020)
  • Efficacy of Photobiomodulation Therapy in Prevention of Grade 3 Mucositis [ Time Frame: day 1 of conditioning to Day +20 of transplant or engraftment ]
    Efficacy will be assessed with assessment of grade 3 mucositis development from day 1 of conditioning to Day +20 of transplant or engraftment as a binary outcome (yes/no) Daily observation: The observation of oral mucositis will be conducted by non-study staff and conducted as clinical care by the nurse, advanced practice provider and/or physician. Assessment: Each patient or parent proxy will complete the Children's Mucositis Assessment via ipad along with documentation of mucositis grade, duration, days of nutrition support, use of narcotics, positive oral and blood cultures. Each patient will be matched and compared to a previously treated patient. The comparison will be matched on primary disease, conditioning regimen, age and sex, with comparison of treatment variables of mucositis grade, duration, pain medications, days of nutritional support, blood and oral cultures, to day +20 or engraftment (depending upon which occurs first).
  • Feasibility of Photobiomodulation Delivery in Prevention of Grade 3 Mucositis [ Time Frame: day 1 of conditioning to Day +20 of transplant or engraftment ]
    Feasibility will be assessed through the number of successful treatments administered by the total number of attempted treatments, providing the percentage of successful treatment administered. Daily treatment will include 6 sites of PBM application, with application documented as receiving all 6 applications, in part treatment (at least one to five sites) or no treatment. A successful treatment is defined as the treatment is successfully administered to 4 or more sites. Reasons for partial or no treatment will be documented. Criteria for feasibility is that the percentage of successful treatments administered exceeds 75%. The collected data will be summarized for total days on protocol, days treatment is received, cumulative dose and the number of treatments received at each site.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 10, 2020)
Development and Duration of Oral Mucositis Between Those Treated with Photobiomodulation and matched control [ Time Frame: day 1 of conditioning to Day +20 of transplant or engraftment ]
Each patient will be matched and compared to a previously treated patient. The comparison will be matched on primary disease, conditioning regimen, age and sex, with comparison of mucositis grade and duration. Patients will be observed daily with documentation of mucositis onset and grade of mucositis. This will be compared to retrospective chart review of previously transplanted patients matched on treatment variables.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prevention of Oral Mucositis Using Photobiomodulation Therapy
Official Title  ICMJE Prevention of Oral Mucositis in Children and Adolescents Undergoing Hematopoietic Stem Cell Transplant Using Photobiomodulation Therapy
Brief Summary

Oral mucositis is a significant and common toxicity experienced by patients who receive high-dose chemotherapy as a preparatory regimen for a hematopoietic cell transplant (HCT). Furthermore, oral mucositis has been reported as the single most debilitating side effect reported by patients undergoing HCT. The incidence of HCT mucositis among adults is estimated to range between 76% and 89%; however, comparisons are difficult due to variability in patient ages, treatments and criteria for scoring oral mucositis.

The use of intra-oral photobiomodulation (PBM) therapy in adult patients after the development of oral mucositis is well documented and now included in the international mucositis guidelines, with limited evidence in pediatrics. This study will build evidence for the incorporation of extra-oral PBM therapy into daily nursing care of children and adolescents undergoing HCT. This intervention has potential in providing evidence for efficacy in the prevention and treatment of oral mucositis, the single most debilitating side effect reported by patients undergoing HCT.

Primary Objective:

  • To evaluate feasibility and efficacy of photobiomodulation therapy (PBM) in reducing oral mucositis in children and adolescents at risk for grade 3 oral mucositis undergoing an allogeneic hematopoietic cell transplant (HCT).

Secondary Objective:

  • To compare clinical manifestations associated with the development of oral mucositis between those treated with daily PBM and a matched control. Clinical factors to include: grade and duration or oral mucositis.

Exploratory Objective:

  • To evaluate efficacy of photobiomodulation therapy in autologous patients at risk for grade 3 oral mucositis compared to matched control.
  • To evaluate utilization of play-based procedural preparation and treatment feasibility and parental satisfaction.
Detailed Description

Children, adolescents and young adults admitted for an allogeneic HCT and those determined by the transplant team to be at risk for grade 3 oral mucositis will be eligible to receive PBM (34 x 660nm 10mW, 35 x 850nm 30mW: 1390 mW total power output) at an irradiance of 50mW/cm2. The PBM treatment will be administered via the THOR Model LX2M unit.

After low light therapy consent, participants will be offered the opportunity to receive a play-based preparation. Those who elect to receive this child life preparation will be scheduled to meet with a trained certified child life specialist (CCL) prior to admission. The play-based preparation will incorporate age and developmentally appropriate explanations of the non-invasive procedure and will be adapted to each patient's psychosocial and cognitive developmental needs.

Observation and treatment will begin the first day of conditioning (plus/minus 2 days). Those undergoing an allogeneic HCT will have treatment daily until Day +20 or engraftment (ANC ≥ 500 for two consecutive days). For those undergoing an autologous transplant, treatment will continue until engraftment (ANC ≥ 500 for two consecutive days) or until the patient is without mucositis for two consecutive days.

The PBM will be administered extra-oral and intra-oral by trained research staff. Direct aim of the laser into the eye will be avoided and safety spectacles will be used with laser therapy. The safety spectacles will be prescribed according to age, with the adjustable Ibis Infant eye protection for patients less than 1 year of age and the adjustable kids laser safety googles for the young child. Patients, staff, and observers will wear laser safety glasses while PBM is in use.

The parent may hold the device in place with assistance from the trained persons. After the initial LLLT treatment, a parent-reported satisfaction survey will be administered via paper questionnaire.

The observation of oral mucositis will be conducted by non-study staff and conducted as clinical care by the nurse, advanced practice provider and/or physician. Each patient will have a daily oral assessment, with documentation of mucositis, grade, duration, pain assessment, days of nutrition support, use of narcotics, positive oral and blood cultures. All patients will receive the standard mouth care regimen prescribed for transplant patients.

Each patient will be matched and compared to a previously treated patient. The comparison will be matched on primary disease, conditioning regimen, age and sex, with comparison of treatment variables of mucositis grade, duration, pain medications, days of nutritional support, blood and oral cultures, to day +20 or engraftment (depending upon which occurs first).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Oral Mucositis
Intervention  ICMJE
  • Device: Photobiomodulation Therapy (PBM)
    The PBM will be delivered through application of the LED Cluster Probe externally to the right external buccal, left external buccal, mid face with mouth open and submandibular and left/right cervical. Patients who develop an oral lesion, intra-oral directed therapy will be administered with the dental light probe. For patients that can tolerate, an intraoral probe will deliver light directly onto the oral mucosa, this will then replace the mid face application with mouth open. Each laser application will be timed at 60 seconds.
    Other Names:
    • THOR 69 diode LED cluster probe (1390mW)
    • PBM therapy
  • Other: Pain and Oral Function Assessment
    After the 6-minute laser/ treatment session the child and parent will complete the mucositis evaluation scale on paper or ipad which includes self-report oral function specific to ability to swallow, eat and drink, as well as the patient's self-reported need for medication specific to mouth pain.
    Other Name: Mucositis Evaluation Scale
  • Other: Parent-Reported Satisfaction Survey
    A parent-reported satisfaction survey will be administered via paper questionnaire after the initial LLLT treatment. Parent satisfaction will be reported by parents on a 5-point Likert scale to questions adapted from a parent satisfaction survey used in a study regarding child life services in pediatric imaging.
    Other Name: Survey
Study Arms  ICMJE Experimental: Photobiomodulation Therapy (PBM)
The PBM will be administered extra-oral and intra-oral.
Interventions:
  • Device: Photobiomodulation Therapy (PBM)
  • Other: Pain and Oral Function Assessment
  • Other: Parent-Reported Satisfaction Survey
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 10, 2020)
66
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 30, 2021
Actual Primary Completion Date May 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • No age limitation
  • To be admitted for an allogeneic hematopoietic cell transplant
  • All eligible autologous hematopoietic cell transplant, at risk for grade 3 mucositis per transplant service secondary to conditioning regimen or previous history of grade 3 mucositis
  • Dental exam prior to admission, as per preadmission criteria
  • Willingness of research participant to provide assent/consent and parent/ legal guardian/representative to give written informed consent.

Exclusion Criteria:

  • Deemed by transplant team as unable to participate
  • Known sensitivity to light therapy
  • Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.
  • CAR-Tcell Protocol
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04227340
Other Study ID Numbers  ICMJE PrOM
NCI-2020-00101 ( Registry Identifier: NCI Clinical Trial Registration Program )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Individual participant de-identified datasets containing the variables analyzed in the published article will be made available (related to the study primary or secondary objectives contained in the publication). Supporting documents such as the protocol, statistical analyses plan, and informed consent are available through the CTG website for the specific study. Data used to generate the published article will be made available at the time of article publication. Investigators who seek access to individual level de-identified data will contact the computing team in the Department of Biostatistics (ClinTrialDataRequest@stjude.org) who will respond to the data request.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Time Frame: Data will be made available at the time of article publication.
Access Criteria: Data will be provided to researchers following a formal request with the following information: full name of requestor, affiliation, data set requested, and timing of when data is needed. As an informational point, the lead statistician and study principal investigator will be informed that primary results datasets have been requested.
Responsible Party St. Jude Children's Research Hospital
Study Sponsor  ICMJE St. Jude Children's Research Hospital
Collaborators  ICMJE Association of Pediatric Hematology Oncology Nurses
Investigators  ICMJE
Principal Investigator: Belinda Mandrell, PhD, RN St. Jude Children's Research Hospital
PRS Account St. Jude Children's Research Hospital
Verification Date August 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP