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NCT02119897 · ClinicalTrials.gov registry record · NA
Feasibility Study of Low Level Light Therapy for Prevention of Oropharyngeal Mucositis in Pediatric Transplants Patients
A NA study, sponsored by Dana-Farber Cancer Institute.
- Completed
- Registry status
- NA
- Development phase
- 13
- Enrollment target
NCT02119897: Completed NA study, sponsored by Dana-Farber Cancer Institute.
NCT02119897 is a NA study that has completed, run by Dana-Farber Cancer Institute. The registered enrollment target is 13 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02119897, a NA study, has completed, sponsored by Dana-Farber Cancer Institute.
- COMPLETED
- Registry status
- NA
- Development phase
- 13 participants
- Enrollment target
Study Summary
Oral mucositis (OM) is a painful and potentially debilitating acute toxicity that frequently affects children undergoing hematopoietic cell transplantation (HCT). As a result of intensive conditioning with chemotherapy with or without total body irradiation, and in the case of allogeneic HCT, graft-versus-host disease (GVHD) prophylaxis, patients are at risk for developing diffuse ulcerations of the oral and esophageal mucosa that result in pain and suffering, increased utilization of opioid analgesics, and the need for intravenous or total parenteral nutritional support. Patients universally report OM as being the worst aspect of the HCT experience.A novel approach has been the use of larger light-emitting diode arrays to treat the at risk tissues from an extraoral approach, enabling exposure of the oral, oropharyngeal, and esophageal mucosa while avoiding the need for intraoral manipulation, and requiring only minimal patient cooperation. In this research study, the investigators are assessing the feasibility of providing extraorally delivered low level light therapy (LLLT) for the prevention of OM in children undergoing myeloablative HCT.
Primary Outcome
Several measures will be collected to evaluate the overall feasibility of providing daily extraoral LLLT for children undergoing HSCT including: * Accessibility and maneuverability of the LLLT device (transportation from storage site to hospital room, device weight) * Administration of LLLT (device settings, positioning of device, delivery of therapy) * Patient tolerability (level of comfort during treatments, compliance with daily therapy * Proportion of days with therapy administered, as evid
Interventions
- DEVICE Low Level Light Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2014-04 |
| Est. Completion | 2016-04 |
| Phase | NA |
What the finished NCT02119897 record still lists
NCT02119897 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Low Level Light Therapy is the first listed.
NCT02119897 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02119897 about?
NCT02119897 is a clinical study titled "Feasibility Study of Low Level Light Therapy for Prevention of Oropharyngeal Mucositis in Pediatric Transplants Patients". Oral mucositis (OM) is a painful and potentially debilitating acute toxicity that frequently affects children undergoing hematopoietic cell transplantation (HCT). As a result of intensive conditioning with chemotherapy with or without total body irradiation, and in the case of allogeneic HCT, graft-...
What is the current status of trial NCT02119897?
This trial is currently completed. It is a NA study. The enrollment target is 13 participants. The study started on 2014-04. Estimated completion is 2016-04.
What interventions are being tested in trial NCT02119897?
The interventions under investigation include: Low Level Light Therapy (DEVICE).
Who is sponsoring clinical trial NCT02119897?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02119897's enrollment target sits among peer trials
13 1911th of 2000 higher than 88 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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
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