Using coconut oil mouth rinse to prevent mouth sores in kids undergoing chemotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to determine if a mouth rinse made from virgin coconut oil (VCO) can effectively prevent oral mucositis in pediatric patients receiving high-dose chemotherapy. The study will compare the standard mucositis prevention rinses with the addition of VCO to assess the severity of oral mucositis between the two groups. Participants aged 7 to 26 years will be enrolled and monitored from the start of their conditioning regimen through 45 days post-transplant or until hospital discharge. The trial is randomized and open-label, ensuring a thorough evaluation of the intervention's effectiveness.

Why it matters

Who can join: the full rules

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

Where it's running

• Atrium Health Levine Children's Hospital
  Charlotte, North Carolina, United States Recruiting

Study contacts

• Principal investigator: Courtney Huddle, DCN, RDN, CSPCC, LDN — Wake Forest University Health Sciences
• Study coordinator: Sceria Jenkins, RN
• Email: sceria.jenkins@advocatehealth.org
• Phone: 980-442-2323

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Amimestrocel infusion to prevent severe mouth sores after allogeneic stem cell transplant

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.