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

NCT ID: NCT05441813

Last Updated: 2026-01-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-15
• Study Completion Date: 2036-07-31

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.

Detailed Description

This is a randomized, open-label study. The target population is patients ≥ 7 years to 26 years at time of consent who are planning to undergo myeloablative conditioning regimens in preparation HSCT. The study will be conducted at Levine Children's Hospital, Levine Children's Cancer and Blood Disorders Clinic and Atrium Health. Subjects will be screened and consented within 28 days prior to admission. The planned treatment period for Arm A (standard of care with the addition of VCO mouth rinses) or Arm B (standard of care) will begin at the start of subject's admission for conditioning, followed by transplant event with day of transplant defined as Day 0 and continue through Day +45 following transplant or hospital discharge, whichever comes first. A Safety Follow Up Visit will occur no sooner than 30 days from last study drug treatment

Conditions

Oral Mucositis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Standard of care + virgin coconut oil

Arm A: Standard of care + virgin coconut oil

Group Type: EXPERIMENTAL

Virgin Coconut Oil

Intervention Type: DRUG

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

Standard of Care

Arm B: Standard of care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Virgin Coconut Oil

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 26 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Courtney Huddle, MSN, RDN, CSPCC, LDN

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Atrium Health Levine Children's Hospital

Charlotte, North Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Sceria Jenkins, RN

Role: CONTACT

sceria.jenkins@atriumhealth.org

980-442-2323

Marithza Amaya

Role: CONTACT

marirthza.amaya@atriumhealth.org

980-442-0530

Other Identifiers

Pro00061628

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-2024-06522

Identifier Type: OTHER

Identifier Source: secondary_id

LCI-PED-BMT-MUC-001

Identifier Type: -

Identifier Source: org_study_id