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N/A N=43 Prevention

Prevention of Oral Mucositis Using Photobiomodulation Therapy

Oral Mucositis

Enrolled (actual)
43
Serious AEs
0.0%
Results posted
Oct 2022
Primary outcome: Primary: 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). — 93 percentage of successful treatments

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Photobiomodulation Therapy (PBM) (Device); Pain and Oral Function Assessment (Other); Parent-Reported Satisfaction Survey (Other)
Age
Pediatric, Adult, Older Adult
Sex
All
Sponsor
St. Jude Children's Research Hospital
Primary completion
May 2021

Outcome Measures

OutcomeResultp-value
PRIMARY
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).
93
PRIMARY
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).
8
SECONDARY
Assess the Severity of Mucositis Grade 1-3 and Duration for Each Patient Treated With PBM Compared to Matched Controls
143; 177; 80; 178; 19; 46 0.03 sig
SECONDARY
Compare the Mucositis Grade and Duration Between Those Who Received PBM and Match Control.
0.47; 1.15; 0.81
SECONDARY
Compare the Mucositis Grade and Duration Between Those Who Received PBM and Match Control
0; 0; 0 0.1
SECONDARY
Compare the Mucositis Grade and Duration Between Those Who Received PBM and Match Control
0; 0; 0 0.1
SECONDARY
Compare the Mucositis Grade and Duration Between Those Who Received PBM and Match Control.
0.47; 1.15; 0.81
SECONDARY
Compare the Mucositis Grade and Duration Between Those Who Received PBM and Match Control
0; 0; 0 0.1
SECONDARY
Days of Hospitalization Between Groups
32; 35 0.009 sig

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.

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04227340). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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