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

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

This study is testing if using a mouth rinse made from coconut oil can help prevent mouth sores in kids and young adults undergoing chemotherapy.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 7 Years to 26 Years
• Sex: All
• Sponsor: Wake Forest University Health Sciences (Academic / other)
• Locations: 1 site (Charlotte, North Carolina)
• Trial ID: NCT05441813 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are pediatric patients aged 7 to 26 years who are scheduled to undergo myeloablative conditioning for hematopoietic stem cell transplantation.

Not a fit: Patients with allergies to tree nuts or those who are planned for discharge prior to the study's treatment period may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the incidence and severity of mouth sores in children undergoing chemotherapy.

How similar studies have performed: While the use of coconut oil for oral health is known, this specific application in preventing chemotherapy-induced oral mucositis is novel and has not been extensively tested in prior studies.

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

Where this trial is running

Charlotte, North Carolina

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

Study contacts

• Principal investigator: Courtney Huddle, MSN, RDN, CSPCC, LDN — Wake Forest University Health Sciences
• Study coordinator: Sceria Jenkins, RN

Conditions Oral Mucositis; Prevention; Virgin Coconut Oil; Mouth Rinse