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NCT05441813 · ClinicalTrials.gov registry record · Phase 2
Coconut Oil to Prevent Mouth Sores in Pediatric Patients Receiving High Dose Chemotherapy
A Phase 2 study of Oral Mucositis, sponsored by Wake Forest University Health Sciences.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT05441813: Recruiting Phase 2 study of Oral Mucositis, sponsored by Wake Forest University Health Sciences.
NCT05441813 is a Phase 2 study of Oral Mucositis that is actively recruiting participants, run by Wake Forest University Health Sciences. The registered enrollment target is 60 participants, below the 102-participant average among 10 other Oral Mucositis trials with a reported enrollment target (41% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05441813, a Phase 2 study of Oral Mucositis, is actively recruiting participants, sponsored by Wake Forest University Health Sciences.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to learn if virgin coconut oil (VCO) mouth rinse can help prevent oral mucositis. The Study Investigator will compare standard of care mucositis prevention rinses with the VCO mouth rinse added to the standard of care mucositis prevention rinses. The severity of oral mucositis between the 2 groups will be evaluated. Some of the standard of care rinses that can be used to prevent mucositis are normal saline, Benadryl (diphenhydramine), Mylanta, lidocaine, or other combinations.
Primary Outcome
Using Area Under the Curve (AUC) of the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 mucositis oral grading scale. This is a 5-point ordered-categorical scale ranging from 1 (asymptomatic or mild symptoms) to 5 (death). For subjects not experiencing oral mucositis, a severity grade of zero will be assigned.
Conditions Studied
Interventions
- DRUG Virgin Coconut Oil
Study Locations (1)
North Carolina
- Atrium Health Levine Children's Hospital - Charlotte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2023-02-15 |
| Est. Completion | 2036-07 |
| Phase | Phase 2 |
What NCT05441813 shows while recruiting
NCT05441813 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 102-participant average among 10 other Oral Mucositis trials with a reported enrollment target (41% lower).
The record links to 1 condition, with Oral Mucositis appearing as the primary indexed condition, and to 1 intervention - of which Virgin Coconut Oil is the first listed.
NCT05441813 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT05441813 about?
NCT05441813 is a clinical study titled "Coconut Oil to Prevent Mouth Sores in Pediatric Patients Receiving High Dose Chemotherapy". The purpose of this study is to learn if virgin coconut oil (VCO) mouth rinse can help prevent oral mucositis. The Study Investigator will compare standard of care mucositis prevention rinses with the VCO mouth rinse added to the standard of care mucositis prevention rinses. The severity of oral muc...
What is the current status of trial NCT05441813?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2023-02-15. Estimated completion is 2036-07.
What conditions does trial NCT05441813 study?
This clinical trial studies the following conditions: Oral Mucositis.
What interventions are being tested in trial NCT05441813?
The interventions under investigation include: Virgin Coconut Oil (DRUG).
Who is sponsoring clinical trial NCT05441813?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05441813 being conducted?
This trial has 1 study location across North Carolina. 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 NCT05441813's enrollment target sits among peer trials
60 7th of 10 higher than 3 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
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