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

What this Trial Is About

Researchers are evaluating whether adding virgin coconut oil (VCO) mouth rinse to standard care rinses can help prevent oral mucositis in pediatric patients receiving high-dose chemotherapy before hematopoietic stem cell transplant (HSCT). This Phase 2 randomized, open-label study compares the severity of oral mucositis between patients using standard care rinses alone and those using standard care plus VCO. The study targets patients aged 7 to 26 years undergoing myeloablative conditioning for HSCT. Participants will be randomly assigned to one of two groups: Arm A will receive standard mucositis prevention rinses plus the VCO mouth rinse, while Arm B will receive the standard care rinses alone. The treatment period starts upon admission for conditioning and continues through transplant day (Day 0) to Day +45 post-transplant or hospital discharge, whichever occurs first. After this, a safety follow-up visit will take place at least 30 days after the last study treatment. During the study, participants will be monitored for oral mucositis severity, daily caloric intake, opioid use, nutritional support needs, mouth rinse use, oral viral infections, length of hospitalization, and time to immune recovery. Assessments occur up to Day 45 post-transplant. The study involves regular clinical evaluations, adherence to mouth rinse use, and a follow-up safety visit to ensure participant well-being throughout the trial period.

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