Actively Recruiting

Phase 2
Age: 7Years - 26Years
All Genders
NCT05441813

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

Led by Wake Forest University Health Sciences · Updated on 2026-01-07

60

Participants Needed

1

Research Sites

697 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 7Years - 26Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Written informed consent and HIPAA authorization obtained from participant or guardian
  • Age between 7 and 26 years at time of consent
  • Planned myeloablative conditioning regimen before hematopoietic stem cell transplant (HSCT)
  • ECOG Performance Status C= 2 or Lansky/Karnofsky Performance Status E= 50 within 7 days before enrollment
  • No mouth lesions at enrollment
  • Ability of participant and caregiver to understand and follow study procedures
  • Able and willing to swish and spit the oral rinse
Not Eligible

You will not qualify if you...

  • Allergy to tree nuts
  • Planned discharge home before engraftment
  • Use of coconut oil mouth rinses within 30 days before enrollment
  • Use of other mouthcare regimens not allowed by institutional standards prior to admission
  • Received HSCT within 90 days before admission

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Atrium Health Levine Children's Hospital

Charlotte, North Carolina, United States, 28203

Actively Recruiting

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Research Team

S

Sceria Jenkins, RN

CONTACT

M

Marithza Amaya

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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