Coconut Oil to Prevent Mouth Sores in Pediatric Patients Receiving High Dose Chemotherapy
A Randomized, Open-label Study of Coconut Oil Mouth Rinse for Prophylaxis of Severe Oral Mucositis in Pediatric Patients Receiving Myeloablative Conditioning Regimens
Wake Forest University Health Sciences
60 participants
Feb 15, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria7
- 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 Criteria6
- 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
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Interventions
Standard of care with the addition of virgin coconut oil mouth rinse
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05441813