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Actively Recruiting

Phase 2
Age: 7Years - 26Years
All Genders
ID05441813

Study Evaluating Virgin Coconut Oil Mouth Rinse to Prevent Severe Mouth Sores in Children and Young Adults Undergoing High Dose Chemotherapy and Stem Cell Transplant

Led by Wake Forest University Health Sciences · Updated on 2026-07-22

60

Participants Needed

1

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating whether using a virgin coconut oil VCO mouth rinse can help prevent oral mucositis in children and young adults aged 7 to 26 years undergoing high dose chemotherapy followed by hematopoietic stem cell transplantation HSCT. The study compares the standard mucositis prevention rinses alone to the standard rinses combined with VCO to assess differences in the severity of mouth sores. Participants will be randomly assigned to one of two groups one receiving the standard care mouth rinses plus the VCO rinse, and the other receiving only the standard care rinses. Treatments start at hospital admission for conditioning chemotherapy and continue through the transplant and up to 45 days after transplant or hospital discharge. A safety follow-up visit will occur at least 30 days after the last study treatment. During the study, participants will be monitored for the severity of mucositis, daily calorie intake, use of total parenteral nutrition and opioids, timing of mucositis progression, mouth rinse use, oral viral infections, length of hospital stay, and time to neutrophil recovery. Researchers will conduct evaluations through Day 45 post-transplant, with ongoing safety assessments after treatment ends. The total participation time is approximately 1.5 months following transplant.

CONDITIONS

Brief Title

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

Research Team

S

Sceria Jenkins, RN

M

Marithza Amaya

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