NCT05441813 Coconut Oil to Prevent Mouth Sores in Pediatric Patients Receiving High Dose Chemotherapy
| NCT ID | NCT05441813 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Wake Forest University Health Sciences |
| Condition | Oral Mucositis |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2023-02-15 |
| Primary Completion | 2036-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 60 participants in total. It began in 2023-02-15 with a primary completion date of 2036-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to learn if virgin coconut oil (VCO) mouth rinse can help prevent oral mucositis. The Study Investigator will compare standard of care mucositis prevention rinses with the VCO mouth rinse added to the standard of care mucositis prevention rinses. The severity of oral mucositis between the 2 groups will be evaluated. Some of the standard of care rinses that can be used to prevent mucositis are normal saline, Benadryl (diphenhydramine), Mylanta, lidocaine, or other combinations.
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
Contact & Investigator
Courtney Huddle, DCN, RDN, CSPCC, LDN
PRINCIPAL INVESTIGATOR
Wake Forest University Health Sciences
Frequently Asked Questions
Who can join the NCT05441813 clinical trial?
This trial is open to participants of all sexes, aged 7 Years or older, up to 26 Years, studying Oral Mucositis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05441813 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05441813 currently recruiting?
Yes, NCT05441813 is actively recruiting participants. Contact the research team at sceria.jenkins@advocatehealth.org for enrollment information.
Where is the NCT05441813 trial being conducted?
This trial is being conducted at Charlotte, United States.
Who is sponsoring the NCT05441813 clinical trial?
NCT05441813 is sponsored by Wake Forest University Health Sciences. The principal investigator is Courtney Huddle, DCN, RDN, CSPCC, LDN at Wake Forest University Health Sciences. The trial plans to enroll 60 participants.