Recruiting
Phase 2

Coconut Oil

Sponsor:

Wake Forest University Health Sciences

Code:

NCT05441813

Conditions

Oral Mucositis

Eligibility Criteria

Sex: All

Age: 7 - 26

Healthy Volunteers: Not accepted

Interventions

Virgin Coconut Oil

Study Details

Brief 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.

Conditions

Oral Mucositis

Study ID

NCT05441813

Start date

Feb 15, 2023

Status verified date

Jul, 2026

Completion date

Jul, 2036

Anticipated

Primary completion date

Jul, 2036

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 7 - 26

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Standard of care + virgin coconut oil

Arm A: Standard of care + virgin coconut oil

no intervention: Standard of Care

Arm B: Standard of care

Interventions

Virgin Coconut Oil

Standard of care with the addition of virgin coconut oil mouth rinse

Primary outcome measure

  • Severity of Mucositis [ Time Frame: Day 45 ]

Central Contacts and Locations

Locations

Atrium Health Levine Children's Hospital

Recruiting

Charlotte, North Carolina, United States, 28203

Principal Investigator:

Courtney Huddle, DCN, RDN, CSPCC, LDN

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Jul 22, 2026

Last verified

Jul, 2026

Keywords

  • Prevention
  • Virgin Coconut Oil
  • Mouth Rinse

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-07-22.