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

Description

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

Talk to us

Study Overview

On this page

Study Details

Study overview

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.

A Randomized, Open-label Study of Coconut Oil Mouth Rinse for Prophylaxis of Severe Oral Mucositis in Pediatric Patients Receiving Myeloablative Conditioning Regimens

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

Condition
Oral Mucositis
Intervention / Treatment

-

Contacts and Locations

Charlotte

Atrium Health Levine Children's Hospital, Charlotte, North Carolina, United States, 28203

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 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
  • 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

Ages Eligible for Study

7 Years to 26 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Wake Forest University Health Sciences,

Courtney Huddle, MSN, RDN, CSPCC, LDN, PRINCIPAL_INVESTIGATOR, Wake Forest University Health Sciences

Study Record Dates

2025-08