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

Launched by WAKE FOREST UNIVERSITY HEALTH SCIENCES · Jun 27, 2022

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ClinConnect Summary

This clinical trial is studying whether using virgin coconut oil (VCO) as a mouth rinse can help prevent mouth sores, known as oral mucositis, in young patients receiving high doses of chemotherapy. The researchers will compare the effects of standard mouth rinse treatments with the addition of VCO to see if it makes a difference in the severity of mouth sores. This trial is open to individuals aged 7 to 26 who are preparing for a specific type of treatment for blood disorders or cancers, called hematopoietic stem cell transplantation (HSCT).

To participate, patients must not have mouth sores at the start of the study and should be able to follow the study’s procedures, including swishing and spitting out the mouth rinse. It’s important to note that those with tree nut allergies or who have used coconut oil mouth rinses recently will not be eligible. If you or someone you know fits the criteria and is interested, this study could provide valuable insights into a new way to manage mouth sores during treatment. Participants will be closely monitored throughout the trial to evaluate how well the mouth rinses work.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Subject must meet all the following applicable inclusion criteria to participate in this study:
• • 1. Written informed consent, HIPAA authorization for release of personal health information, and assent, when applicable from the subject, parent, or legal guardian.
• • 2. Age greater than or equal to 7 years to 26 years at the time of consent
• • 3. Patients planning to undergo myeloablative conditioning regimens in preparation for HSCT
• • 4. 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.
• • 5. No evidence of mouth lesions at time of enrollment
• • 6. Ability of the subject and parent/caregiver to understand and comply with study procedures for the entire length of the study
• • 7. Able and willing to swish/spit the oral formulation
• Exclusion Criteria:
• Subjects meeting any of the criteria below may not participate in the study:
• • 1. Allergy to tree nuts
• • 2. Planned discharge home prior to engraftment
• • 3. Using coconut oil mouth rinses within 30 days prior to enrollment
• • 4. Using additional mouthcare regimens, other than those allowed in the institutional SOP, prior to admission with a plan to continue use during admission
• • 5. Patient has undergone HSCT within the last 90 days prior to admission