NCT04227340

Prevention of Oral Mucositis Using Photobiomodulation Therapy

Completed NA Results posted Last updated 4 October 2022

What this trial tests

NA trial testing Photobiomodulation Therapy (PBM) in Oral Mucositis in 43 participants. Completed in 30 May 2021.

Timeline

4 February 2020

Primary endpoint
30 May 2021

30 May 2021

Quick facts

Lead sponsor	St. Jude Children's Research Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	43
Start date	4 February 2020
Primary completion	30 May 2021
Estimated completion	30 May 2021
Sites	1 location across United States

Drugs / interventions tested

• Photobiomodulation Therapy (PBM)
• Pain and Oral Function Assessment
• Parent-Reported Satisfaction Survey

Conditions studied

• Oral Mucositis — all drugs for Oral Mucositis →

Sponsor

St. Jude Children's Research Hospital

Who can join

Eligibility, any sex, with Oral Mucositis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

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%.

Group	Value	95% CI
Photobiomodulation Therapy (PBM)	93	93 – 94

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

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.

Group	Value	95% CI
Photobiomodulation Treated	8

Assess the Severity of Mucositis Grade 1-3 and Duration for Each Patient Treated With PBM Compared to Matched Controls Secondary · Daily assessment from day 1 of conditioning to 20 days after transplant or engraftment (2 consecutive days of an Absolute Neutrophil Count (ANC)>500)

Patients were ranked according to the severity of their mucositis (a weighted average of mucositis intensity (grade 1-3) by number of days duration)

Grade 1

Group	Value	95% CI
Photobiomodulation Treated	143
Historical Matched Controls	177

Grade 2

Group	Value	95% CI
Photobiomodulation Treated	80
Historical Matched Controls	178

Grade 3

Group	Value	95% CI
Photobiomodulation Treated	19
Historical Matched Controls	46

Compare the Mucositis Grade and Duration Between Those Who Received PBM and Match Control. Secondary · Daily assessment from day 1 of conditioning to 20 days after transplant or engraftment (2 consecutive days of an Absolute Neutrophil Count (ANC)>500)

Participants treated with PBM therapy were matched to a transplant control who was not treated with PBM. Patients were matched by age, sex, primary disease and transplant conditioning regimen. Total days of grade 1 OM were calculated between PBM treated and untreated

Group	Value	95% CI
Photobiomodulation Treated	3.58	± 2.91
Historical Matched Controls	4.43	± 3.85
Overall	4	± 3.42

Compare the Mucositis Grade and Duration Between Those Who Received PBM and Match Control Secondary · Daily assessment from day 1 of conditioning to 20 days after transplant or engraftment (2 consecutive days of an Absolute Neutrophil Count (ANC)>500)

Participants treated with PBM therapy were matched to a transplant control who was not treated with PBM. Patients were matched by age, sex, primary disease and transplant conditioning regimen. Total days of grade 1 OM were calculated between PBM treated and untreated.

Group	Value	95% CI
Photobiomodulation Treated	3	0 – 10
Historical Matched Controls	4	0 – 19
Overall	4	0 – 19

Compare the Mucositis Grade and Duration Between Those Who Received PBM and Match Control Secondary · Daily assessment from day 1 of conditioning to 20 days after transplant or engraftment (2 consecutive days of an Absolute Neutrophil Count (ANC)>500)

Participants treated with PBM therapy were matched to a transplant control who was not treated with PBM. Patients were matched by age, sex, primary disease and transplant conditioning regimen. Total days of grade 2 OM were calculated between PBM treated and untreated.

Group	Value	95% CI
Photobiomodulation Treated	2	± 2.10
Historical Matched Controls	4.45	± 4.99
Overall	3.23	± 4

Compare the Mucositis Grade and Duration Between Those Who Received PBM and Match Control Secondary · Daily assessment from day 1 of conditioning to 20 days after transplant or engraftment (2 consecutive days of an Absolute Neutrophil Count (ANC)>500)

Participants treated with PBM therapy were matched to a transplant control who was not treated with PBM. Patients were matched by age, sex, primary disease and transplant conditioning regimen. Total days of grade 2 OM were calculated between PBM treated and untreated.

Group	Value	95% CI
Photobiomodulation Treated	1.5	0 – 6
Historical Matched Controls	2.5	0 – 16
Overall	2	0 – 16

Compare the Mucositis Grade and Duration Between Those Who Received PBM and Match Control. Secondary · Daily assessment from day 1 of conditioning to 20 days after transplant or engraftment (2 consecutive days of an Absolute Neutrophil Count (ANC)>500)

Participants treated with PBM therapy were matched to a transplant control who was not treated with PBM. Patients were matched by age, sex, primary disease and transplant conditioning regimen. Total days of grade 3 OM were calculated between PBM treated and untreated.

Group	Value	95% CI
Photobiomodulation Treated	0.47	± 1.15
Historical Matched Controls	1.15	± 2.18
Overall	0.81	± 1.77

Compare the Mucositis Grade and Duration Between Those Who Received PBM and Match Control Secondary · Daily assessment from day 1 of conditioning to 20 days after transplant or engraftment (2 consecutive days of an Absolute Neutrophil Count (ANC)>500)

Participants treated with PBM therapy were matched to a transplant control who was not treated with PBM. Patients were matched by age, sex, primary disease and transplant conditioning regimen. Total days of grade 3 OM were calculated between PBM treated and untreated.

Group	Value	95% CI
Photobiomodulation Treated	0	0 – 5
Historical Matched Controls	0	0 – 8
Overall	0	0 – 8

Days of Hospitalization Between Groups Secondary · From the time of admission to discharge

Total days of hospitalization between the treated and control group

Group	Value	95% CI
Photobiomodulation Treated	32.4	± 6.40
Historical Matched Controls	40.2	± 15.7

Days of Hospitalization Between Groups Secondary · From the time of admission to discharge

Total days of hospitalization between the treated and control group

Group	Value	95% CI
Photobiomodulation Treated	32	23 – 49
Historical Matched Controls	35	23 – 105

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.