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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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for mouth sores, such as Virgin Coconut Oil (VCO), work primarily through their anti-inflammatory and antimicrobial properties. The anti-inflammatory action helps to reduce swelling, pain, and redness associated with mouth sores, providing relief and promoting healing. The antimicrobial properties help to prevent or reduce infection by targeting harmful bacteria and other pathogens that can exacerbate sores. These mechanisms are crucial for mouth sore patients as they not only alleviate symptoms but also prevent complications, leading to faster recovery and improved oral health.
Oropharyngeal Decontamination with Antiseptics to Prevent Ventilator-Associated Pneumonia: Rethinking the Benefits of Chlorhexidine.A better definition of counselling strategies is needed to define effectiveness in temporomandibular disorders management.Treatment of oral malodour. Medium-term efficacy of mechanical and/or chemical agents: a systematic review.

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,253 Previous Clinical Trials
1,010,872 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
~27 spots leftby Aug 2025