RecruitingPhase 2

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

United States60 participantsStarted 2023-02-15

Plain-language 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.

Who can participate

Age range7 Years – 26 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Written informed consent, HIPAA authorization for release of personal health information, and assent, when applicable from the subject, parent, or legal guardian.
✓. Age greater than or equal to 7 years to 26 years at the time of consent
✓. Patients planning to undergo myeloablative conditioning regimens in preparation for HSCT
✓. 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.
✓. No evidence of mouth lesions at time of enrollment
✓. Ability of the subject and parent/caregiver to understand and comply with study procedures for the entire length of the study
✓. Able and willing to swish/spit the oral formulation

Exclusion criteria

✕. Allergy to tree nuts
✕. Planned discharge home prior to engraftment
✕. Using coconut oil mouth rinses within 30 days prior to enrollment
✕. Using additional mouthcare regimens, other than those allowed in the institutional SOP, prior to admission with a plan to continue use during admission
✕. Patient has undergone HSCT within the last 90 days prior to admission

What they're measuring

Severity of Mucositis

Timeframe: Day 45

Trial details

NCT IDNCT05441813

SponsorWake Forest University Health Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2036-07

Contact for this trial

Sceria Jenkins, RN

980-442-2323 sceria.jenkins@atriumhealth.org

View on ClinicalTrials.gov More Oral Mucositis trials