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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age7-26
SponsorWake Forest University Health Sciences

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Virgin Coconut Oil

Treatment groups

60 Participants
are divided into 2 treatment groups