RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-02-15
Study Completion:2025-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05441813

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.

Ages Eligible for Study:7 Years to 26 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Written informed consent, HIPAA authorization for release of personal health information, and assent, when applicable from the subject, parent, or legal guardian.
  2. 2. Age greater than or equal to 7 years to 26 years at the time of consent
  3. 3. Patients planning to undergo myeloablative conditioning regimens in preparation for HSCT
  4. 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. 5. No evidence of mouth lesions at time of enrollment
  6. 6. Ability of the subject and parent/caregiver to understand and comply with study procedures for the entire length of the study
  7. 7. Able and willing to swish/spit the oral formulation
  1. 1. Allergy to tree nuts
  2. 2. Planned discharge home prior to engraftment
  3. 3. Using coconut oil mouth rinses within 30 days prior to enrollment
  4. 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. 5. Patient has undergone HSCT within the last 90 days prior to admission

Contacts and Locations

Study Contact

Sceria Jenkins, RN
CONTACT
980-442-2323
sceria.jenkins@atriumhealth.org
Marithza Amaya
CONTACT
980-442-0530
marirthza.amaya@atriumhealth.org

Principal Investigator

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

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Wake Forest University Health Sciences

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-15
Study Completion Date2025-08

Study Record Updates

Study Start Date2023-02-15
Study Completion Date2025-08

Terms related to this study

Keywords Provided by Researchers

  • Prevention
  • Virgin Coconut Oil
  • Mouth Rinse

Additional Relevant MeSH Terms

  • Oral Mucositis