Prevention of Oral Mucositis Using Photobiomodulation Therapy

NCT04227340 | Completed Results FDA Device

• 2 other identifiers: PrOMNCI-2020-00101
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Mucositis

Keywords

Adolescents; Autologous Transplant; Chemotherapy; Children; Extra-oral Photobiomodulation Therapy; HCT; Hematopoietic Stem Cell Transplant; Low Level Light therapy; Oral Mucositis; PBM; Photobiomodulation Therapy

Outcome Measures

Primary Outcomes (2)

• Feasibility of Photo Biomodulation Therapy (PBM) in Reducing Oral Mucositis (OM) in Children and Adolescents at Risk for Grade 3 OM Undergoing an Allogeneic Hematopoietic Cell Transplant (HCT).

  Feasibility was assessed through the number of successful treatments (957) administered by the total number of attempted treatments (1023), providing the percentage of successful treatment administered. Daily treatment included 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 was defined as successfully administered to 4 or more sites. Reasons for partial or no treatment was documented. Criteria for feasibility was 75%.

  Daily assessment from day 1 of conditioning to 20 days after transplant or engraftment (2 consecutive days of an Absolute Neutrophil Count (ANC)>500)

• Efficacy of Photo Biomodulation Therapy (PBM) in Reducing Oral Mucositis (OM) in Children and Adolescents at Risk for Grade 3 OM Undergoing an Allogeneic Hematopoietic Cell Transplant (HCT).

  It was estimated from a retrospective review of HCT patients that 71% of participants undergoing a HCT developed grade 3 mucositis. With an estimated clinically meaningful effect size of 20% for PBM, the estimated percentage of PBM participant to develop grade 3 mucositis was set at 51%. An interim analysis was conducted after the enrollment of 40 participants.

  Daily assessment from day 1 of conditioning to 20 days after transplant or engraftment (2 consecutive days of an Absolute Neutrophil Count (ANC)>500)

Secondary Outcomes (7)

• Assess the Severity of Mucositis Grade 1-3 and Duration for Each Patient Treated With PBM Compared to Matched Controls

  Daily assessment from day 1 of conditioning to 20 days after transplant or engraftment (2 consecutive days of an Absolute Neutrophil Count (ANC)>500)

• Compare the Mucositis Grade and Duration Between Those Who Received PBM and Match Control.

  Daily assessment from day 1 of conditioning to 20 days after transplant or engraftment (2 consecutive days of an Absolute Neutrophil Count (ANC)>500)

• Compare the Mucositis Grade and Duration Between Those Who Received PBM and Match Control

  Daily assessment from day 1 of conditioning to 20 days after transplant or engraftment (2 consecutive days of an Absolute Neutrophil Count (ANC)>500)

• Compare the Mucositis Grade and Duration Between Those Who Received PBM and Match Control

  Daily assessment from day 1 of conditioning to 20 days after transplant or engraftment (2 consecutive days of an Absolute Neutrophil Count (ANC)>500)

• Compare the Mucositis Grade and Duration Between Those Who Received PBM and Match Control.

  Daily assessment from day 1 of conditioning to 20 days after transplant or engraftment (2 consecutive days of an Absolute Neutrophil Count (ANC)>500)

Study Arms (1)

Photobiomodulation Therapy (PBM)

EXPERIMENTAL

The PBM will be administered extra-oral and intra-oral.

Device: Photobiomodulation Therapy (PBM); Other: Pain and Oral Function Assessment; Other: Parent-Reported Satisfaction Survey

Interventions

Photobiomodulation Therapy (PBM) DEVICE

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.

Also known as: THOR 69 diode LED cluster probe (1390mW), PBM therapy

Photobiomodulation Therapy (PBM)

Pain and Oral Function Assessment OTHER

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.

Also known as: Mucositis Evaluation Scale

Photobiomodulation Therapy (PBM)

Parent-Reported Satisfaction Survey OTHER

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.

Also known as: Survey

Photobiomodulation Therapy (PBM)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead
• Association of Pediatric Hematology Oncology Nurses: collaborator

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Links

• St. Jude Children's Research Hospital
• ClinicalTrials Open at St. Jude

MeSH Terms

Conditions

Stomatitis

Interventions

Low-Level Light Therapy; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Results Point of Contact

• Title: Belinda Mandrell, PhD, RN
• Organization: St. Jude Children's Research Hospital

belinda.mandrell@stjude.org

(901) 595-4209

Study Officials

• Belinda Mandrell, PhD, RN

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2020
• First Posted: January 13, 2020
• Study Start: February 4, 2020
• Primary Completion: May 30, 2021
• Study Completion: May 30, 2021
• Last Updated: October 4, 2022
• Results First Posted: October 4, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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.

Locations

US (1)