Standard of care + virgin coconut oil for Oral Mucositis

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Atrium Health Levine Children's Hospital, Charlotte, NC
Oral Mucositis+2 More
Virgin Coconut Oil - Drug
Eligibility
< 65
All Sexes
What conditions do you have?
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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.

Eligible Conditions

  • Oral Mucositis

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 8 Secondary · Reporting Duration: Day 45

Day 45
Average Daily Caloric Intake
Daily Incidence of Optional Mouth Rinses
Days to Absolute Neutrophil Count (ANC) Engraftment
Incidence and type of oral viral infections
Length of Hospitalization
Opioid Use
Oral Rinse Utilization
Severity of Mucositis
Time to CTCAE Mucositis Grade > 2
Total Parenteral Nutrition (TPN)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

4 Treatment Groups

Standard of Care
1 of 4
Arm B
1 of 4
Standard of care + virgin coconut oil
1 of 4
Arm A
1 of 4
Active Control
Experimental Treatment

60 Total Participants · 4 Treatment Groups

Primary Treatment: Standard of care + virgin coconut oil · No Placebo Group · Phase 2

Standard of care + virgin coconut oil
Drug
Experimental Group · 1 Intervention: Virgin Coconut Oil · Intervention Types: Drug
Arm A
Drug
Experimental Group · 1 Intervention: Virgin Coconut Oil · Intervention Types: Drug
Standard of CareNoIntervention Group · 1 Intervention: Standard of Care · Intervention Types:
Arm BNoIntervention Group · 1 Intervention: Arm B · Intervention Types:
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Virgin Coconut Oil
2011
Completed Phase 3
~50

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: day 45
Closest Location: Atrium Health Levine Children's Hospital · Charlotte, NC
Photo of charlotte  1Photo of charlotte  2Photo of charlotte  3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Oral Mucositis
0 CompletedClinical Trials

Eligibility Criteria

Age < 65 · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are able to understand and comply with study procedures for the entire length of the study.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.