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NCT04227340 · ClinicalTrials.gov registry record · NA
Prevention of Oral Mucositis Using Photobiomodulation Therapy
A NA study of Oral Mucositis, sponsored by St. Jude Children's Research Hospital.
- Completed
- Registry status
- NA
- Development phase
- 43
- Enrollment target
- 1
- Study location
NCT04227340: Completed NA study of Oral Mucositis, sponsored by St. Jude Children's Research Hospital.
NCT04227340 is a NA study of Oral Mucositis that has completed, run by St. Jude Children's Research Hospital. The registered enrollment target is 43 participants, below the 103-participant average among 10 other Oral Mucositis trials with a reported enrollment target (58% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04227340, a NA study of Oral Mucositis, has completed, sponsored by St. Jude Children's Research Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 43 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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
Conditions Studied
Interventions
- DEVICE Photobiomodulation Therapy (PBM)
- OTHER Pain and Oral Function Assessment
- OTHER Parent-Reported Satisfaction Survey
Study Locations (1)
Tennessee
- St. Jude Children's Research Hospital - Memphis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2020-02-04 |
| Est. Completion | 2021-05-30 |
| Phase | NA |
What the finished NCT04227340 record still lists
NCT04227340 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 103-participant average among 10 other Oral Mucositis trials with a reported enrollment target (58% lower).
The record links to 1 condition, with Oral Mucositis appearing as the primary indexed condition, and to 3 interventions - of which Photobiomodulation Therapy (PBM) is the first listed.
NCT04227340 reports a single indexed study location in Tennessee.
Frequently Asked Questions
What is clinical trial NCT04227340 about?
NCT04227340 is a clinical study titled "Prevention of Oral Mucositis Using Photobiomodulation Therapy". 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...
What is the current status of trial NCT04227340?
This trial is currently completed. It is a NA study. The enrollment target is 43 participants. The study started on 2020-02-04. Estimated completion is 2021-05-30.
What conditions does trial NCT04227340 study?
This clinical trial studies the following conditions: Oral Mucositis.
What interventions are being tested in trial NCT04227340?
The interventions under investigation include: Photobiomodulation Therapy (PBM) (DEVICE), Pain and Oral Function Assessment (OTHER), Parent-Reported Satisfaction Survey (OTHER).
Who is sponsoring clinical trial NCT04227340?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04227340 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Oral Mucositis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04227340's enrollment target sits among peer trials
43 9th of 10 higher than 2 of 10 other Oral Mucositis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Oral Mucositis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Intraoral Photobiomodulation Therapy to Prevent Oral Mucositis in Patients Undergoing Hematopoietic Cell Transplantation
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RRx-001 for Reducing Oral Mucositis in Patients Receiving Chemotherapy and Radiation for Head and Neck Cancer
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Photobiomodulation for the Prevention of Oral Mucositis
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-
MIT-001 for Prevention of CCRT-Induced OM in HNSCC Patients
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