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.
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.
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
Parallel
Virgin Coconut Oil
DrugStandard of care with the addition of virgin coconut oil mouth rinse
Severity of Mucositis
Using Area Under the Curve (AUC) of the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 mucositis oral grading scale. This is a 5-point ordered-categorical scale ranging from 1 (asymptomatic or mild symptoms) to 5 (death). For subjects not experiencing oral mucositis, a severity grade of zero will be assigned.
Average Daily Caloric Intake
Oral intake will be calculated quantitatively for each subject during the on-treatment period.
Total Parenteral Nutrition (TPN)
TPN or hyperalimentation will be calculated quantitatively for each subject as the proportion of days during the on-treatment period that aggressive nutrition support was utilized.
Opioid Use
Daily opioid use will be calculated quantitatively for each subject in terms of their average Morphine Equivalent Daily Dose (MEDD)
Time to CTCAE Mucositis Grade > 2
The duration of time (in days) from the initiation of study treatment until the day of the first occurrence of a CTCAE mucositis grade exceeding 2. The CTCAE mucositis grade is a 5-point ordered-categorical scale ranging from 1 (asymptomatic or mild symptoms) to 5 (death). For subjects who do not report a grade exceeding 2, time to CTCAE mucositis grade \>2 will be censored at the date of the last completed CTCAE evaluation.
Oral Rinse Utilization
Reported as a percent of utilization
Click on the lead sponsor to view all of their trials.
