Status:
RECRUITING
Coconut Oil to Prevent Mouth Sores in Pediatric Patients Receiving High Dose Chemotherapy
Lead Sponsor:
Wake Forest University Health Sciences
Conditions:
Oral Mucositis
Eligibility:
All Genders
7-26 years
Phase:
PHASE2
Brief 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...
Detailed Description
This is a randomized, open-label study. The target population is patients ≥ 7 years to 26 years at time of consent who are planning to undergo myeloablative conditioning regimens in preparation HSCT. ...
Eligibility Criteria
Inclusion
- Subject must meet all the following applicable inclusion criteria to participate in this study:
- 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.
- No evidence of mouth lesions at time of enrollment
- Ability of the subject and parent/caregiver to understand and comply with study procedures for the entire length of the study
- Able and willing to swish/spit the oral formulation
Exclusion
- Subjects meeting any of the criteria below may not participate in the study:
- 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
- Patient has undergone HSCT within the last 90 days prior to admission
Key Trial Info
Start Date :
February 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2036
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05441813
Start Date
February 15 2023
End Date
July 1 2036
Last Update
January 7 2026
Active Locations (1)
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1
Atrium Health Levine Children's Hospital
Charlotte, North Carolina, United States, 28203