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Coconut oil swish may shield kids from brutal mouth sores during transplant

NCT ID NCT05441813

Prevention Sponsor: Wake Forest University Health Sciences Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 23, 2026 · Updated 2 times

Summary

This study tests if rinsing with virgin coconut oil can prevent severe mouth sores in children and young adults (ages 7-26) getting a bone marrow transplant. About 60 participants will either use standard mouth rinses or add coconut oil to their routine. Researchers will compare how bad mouth sores get and track daily calorie intake.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2023

Expected to finish

Jul 2036

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

7 to 26 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Subject must meet all the following applicable inclusion criteria to participate in this study: 1. Written informed consent, HIPAA authorization for release of personal health information, and assent, when applicable from the subject, parent, or legal guardian. 2. Age greater than or equal to 7 years to 26 years at the time of consent 3. Patients planning to undergo myeloablative conditioning regimens in preparation for HSCT 4. 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. 5. No evidence of mouth lesions at time of enrollment 6. Ability of the subject and parent/caregiver to understand and comply with study procedures for the entire length of the study 7. Able and willing to swish/spit the oral formulation Exclusion Criteria: Subjects meeting any of the criteria below may not participate in the study: 1. Allergy to tree nuts 2. Planned discharge home prior to engraftment 3. Using coconut oil mouth rinses within 30 days prior to enrollment 4. Using additional mouthcare regimens, other than those allowed in the institutional SOP, prior to admission with a plan to continue use during admission 5. Patient has undergone HSCT within the last 90 days prior to admission

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Conditions

The condition(s) this trial relates to.

stomatitis prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Oral mucositis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Atrium Health Levine Children's Hospital

    RECRUITING

    Charlotte, North Carolina, 28203, United States

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