Overview

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

Status:
Not yet recruiting
Trial end date:
2025-08-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Wake Forest University Health Sciences
Criteria
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. As determined by the enrolling physician, 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 as determined by the treating
investigator

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 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