Coconut Oil to Prevent Mouth Sores in Pediatric Patients Receiving High Dose Chemotherapy

Recruiting now · Phase 2

Conditions studied: Oral Mucositis

In brief

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.

Key facts

Study ID: NCT05441813
Run by: Wake Forest University Health Sciences
People needed: 60
Starts: 2023-02-15
Expected to finish: 2036-07-01
Last updated by the study team: 2026-07-22

Who can join

Age: 7 and older, up to 26. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Subject must meet all the following applicable inclusion criteria to participate in this study:
Written informed consent, HIPAA authorization for release of personal health information, and assent, when applicable from the subject, parent, or legal guardian.
Age greater than or equal to 7 years to 26 years at the time of consent
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.
No evidence of mouth lesions at time of enrollment
Ability of the subject and parent/caregiver to understand and comply with study procedures for the entire length of the study
Able and willing to swish/spit the oral formulation

You may not qualify if…

Subjects meeting any of the criteria below may not participate in the study:
Allergy to tree nuts
Planned discharge home prior to engraftment
Using coconut oil mouth rinses within 30 days prior to enrollment
Using additional mouthcare regimens, other than those allowed in the institutional SOP, prior to admission with a plan to continue use during admission
Patient has undergone HSCT within the last 90 days prior to admission

Where it is running

Atrium Health Levine Children's Hospital — Charlotte, North Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

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