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

Part of paid clinical trials in Charlotte, North Carolina.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT05441813
Phase
PHASE2
Status
Recruiting
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Conditions

  • Oral Mucositis

Eligibility Criteria

Sex
ALL
Age
7 Years - 26 Years
Healthy Volunteers
Not accepted

Interventions

  • Virgin Coconut Oil — DRUG
    Standard of care with the addition of virgin coconut oil mouth rinse

Study Details

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.

Key Dates

Start date
Feb 15, 2023
Status verified
Jan 2026
Primary completion
Jul 31, 2036
Completion
Jul 31, 2036

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Standard of care + virgin coconut oil
    Arm A: Standard of care + virgin coconut oil
  • No Intervention: Standard of Care
    Arm B: Standard of care

Primary Outcome Measure

Severity of Mucositis [ Time Frame: Day 45 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Atrium Health Levine Children's HospitalCharlotteNorth Carolina28203
Courtney Huddle, MSN, RDN, CSPCC, LDN (PRINCIPAL_INVESTIGATOR)

Find similar trials in Charlotte, NC

By research site
Atrium Health Levine Children's Hospital· Charlotte, NC

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