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

NCT05441813 | Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: LCI-PED-BMT-MUC-001Pro00061628NCI-2024-06522
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Mucositis

Keywords

Prevention; Virgin Coconut Oil; Mouth Rinse

Outcome Measures

Primary Outcomes (1)

• Severity of Mucositis

  Using Area Under the Curve (AUC) of the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 mucositis oral grading scale. This is a 5-point ordered-categorical scale ranging from 1 (asymptomatic or mild symptoms) to 5 (death). For subjects not experiencing oral mucositis, a severity grade of zero will be assigned.

  Day 45

Secondary Outcomes (8)

• Average Daily Caloric Intake

  Day 45

• Total Parenteral Nutrition (TPN)

  Day 45

• Opioid Use

  Day 45

• Time to CTCAE Mucositis Grade > 2

  Day 45

• Daily Incidence of Optional Mouth Rinses

  Day 45

Other Outcomes (1)

• Oral Rinse Utilization

  Day 45

Study Arms (2)

Standard of care + virgin coconut oil

EXPERIMENTAL

Arm A: Standard of care + virgin coconut oil

Drug: Virgin Coconut Oil

Standard of Care

NO INTERVENTION

Arm B: Standard of care

Interventions

Virgin Coconut Oil DRUG

Standard of care with the addition of virgin coconut oil mouth rinse

Standard of care + virgin coconut oil

Eligibility Criteria

• Age: 7 Years - 26 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Subjects meeting any of the criteria below may not participate in the study:
• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Atrium Health Levine Children's Hospital

Charlotte, North Carolina, 28203, United States

RECRUITING

MeSH Terms

Conditions

Stomatitis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Officials

• Courtney Huddle, MSN, RDN, CSPCC, LDN

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sceria Jenkins, RN

CONTACT

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

Marithza Amaya

CONTACT

980-442-0530; marirthza.amaya@atriumhealth.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2022
• First Posted: July 1, 2022
• Study Start: February 15, 2023
• Primary Completion (Estimated): July 1, 2036
• Study Completion (Estimated): July 1, 2036
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)