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Coconut Oil for Mouth Sores

Phase 2
Recruiting
Led By Courtney Huddle, MSN, RDN, CSPCC, LDN
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients planning to undergo myeloablative conditioning regimens in preparation for HSCT
ECOG Performance Status of less than or equal to 2 or Lansky/Karnofsky Performance Status of greater than or equal to 50 within 7 days prior to date of enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 45
Awards & highlights

Study Summary

This trial is testing whether adding virgin coconut oil to a standard mouth rinse can help prevent oral mucositis.

Who is the study for?
This trial is for pediatric patients aged 7 to 26 years who are about to receive high-dose chemotherapy and have no current mouth sores. They must be able to perform mouth rinses, not have tree nut allergies, and not be using other non-standard oral care regimens or coconut oil rinses recently.Check my eligibility
What is being tested?
The study tests if virgin coconut oil (VCO) can prevent mouth sores when added to standard oral care rinses in children receiving intense chemotherapy. The severity of mouth sores with VCO will be compared against those using only the standard treatment.See study design
What are the potential side effects?
While the side effects aren't detailed here, potential risks may include allergic reactions for those sensitive to coconut products. Generally, VCO is considered safe with minimal risk of adverse effects when used as a rinse.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am preparing for a stem cell transplant with intensive treatment.
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I can care for myself and am up more than 50% of my waking hours.
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I do not have any sores in my mouth.
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I am between 7 and 26 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 45
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 45 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Severity of Mucositis
Secondary outcome measures
Average Daily Caloric Intake
Daily Incidence of Optional Mouth Rinses
Days to Absolute Neutrophil Count (ANC) Engraftment
+5 more
Other outcome measures
Oral Rinse Utilization

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Standard of care + virgin coconut oilExperimental Treatment1 Intervention
Arm A: Standard of care + virgin coconut oil
Group II: Standard of CareActive Control1 Intervention
Arm B: Standard of care
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Coconut oil
Not yet FDA approved

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,242 Previous Clinical Trials
1,004,207 Total Patients Enrolled
Courtney Huddle, MSN, RDN, CSPCC, LDNPrincipal InvestigatorWake Forest University Health Sciences
Courtney Huddle, MSN, RDN, LDNPrincipal InvestigatorWake Forest University Health Sciences

Media Library

Virgin Coconut Oil Clinical Trial Eligibility Overview. Trial Name: NCT05441813 — Phase 2
Mouth Sore Research Study Groups: Standard of care + virgin coconut oil, Standard of Care
Mouth Sore Clinical Trial 2023: Virgin Coconut Oil Highlights & Side Effects. Trial Name: NCT05441813 — Phase 2
Virgin Coconut Oil 2023 Treatment Timeline for Medical Study. Trial Name: NCT05441813 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent is enrollment open for this research endeavor?

"Affirmative. Clinicaltrials.gov hosts a record of the trial's inception on October 10th 2022 and its most recent amendment which occurred four days later. This medical experiment is currently recruiting 60 patients from one location."

Answered by AI

How detrimental is consumption of Virgin Coconut Oil for those using it therapeutically?

"Although there is limited evidence backing the efficacy of Virgin Coconut Oil, our team at Power still gave it a rating of 2 for safety due to its Phase 2 trial status."

Answered by AI

What type of individuals is the ideal candidate for this trial?

"This clinical trial is searching to enrol sixty participants, aged 7-26, who presently suffer from oral mucositis. For eligibility in the study, patients must meet further standards such as written consent and HIPAA authorization for personal health information release; additionally they should demonstrate an ECOG Performance Status of no greater than two or a Lansky/Karnofsky Performance Status of at least fifty within seven days before enrollment date. Also required is that subjects have no visible mouth lesions on admission and are able to comprehend and abide by all study protocols throughout its duration."

Answered by AI

Does this research program admit participants aged sixty or older?

"This clinical trial requires that patients are between the ages of 7-26. Studies for those under 18 amount to 7, while 54 studies are designated for individuals over 65 years old."

Answered by AI

Are there any available openings for participants in this medical trial?

"Yes, according to the information on clinicaltrials.gov, this medical trial is currently recruiting participants. The study was initially uploaded onto 10/10/2022 and subsequently modified on 10/14/2022. Specifically, it aims to enrol 60 volunteers at one of its sites."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+
Recent research and studies
clinicaltrials.govStudy
Coconut Oil to Prevent Mouth Sores in Pediatric Patients Receiving High Dose Chemotherapy
2023. "Coconut Oil to Prevent Mouth Sores in Pediatric Patients Receiving High Dose Chemotherapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05441813.
~31 spots leftby Aug 2025
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