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