Prevention of Oral Mucositis Using Photobiomodulation Therapy

NCT ID: NCT04227340

Last Updated: 2022-10-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-04
• Study Completion Date: 2021-05-30

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).

Conditions

Oral Mucositis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Photobiomodulation Therapy (PBM)

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

Group Type: EXPERIMENTAL

Photobiomodulation Therapy (PBM)

Intervention Type: 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.

Pain and Oral Function Assessment

Intervention Type: 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.

Parent-Reported Satisfaction Survey

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

THOR 69 diode LED cluster probe (1390mW); PBM therapy; Mucositis Evaluation Scale; Survey

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Association of Pediatric Hematology Oncology Nurses

OTHER

Sponsor Role: collaborator

St. Jude Children's Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Belinda Mandrell, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

St. Jude Children's Research Hospital

Locations

St. Jude Children's Research Hospital

Memphis, Tennessee, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Related Links

http://www.stjude.org

St. Jude Children's Research Hospital

http://www.stjude.org/protocols

ClinicalTrials Open at St. Jude

Other Identifiers

NCI-2020-00101

Identifier Type: REGISTRY

Identifier Source: secondary_id

PrOM

Identifier Type: -

Identifier Source: org_study_id