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

Oral Mucositis Clinical Trial

Official title:

A Randomized, Open-label Study of Coconut Oil Mouth Rinse for Prophylaxis of Severe Oral Mucositis in Pediatric Patients Receiving Myeloablative Conditioning Regimens

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05441813
• Other study ID #: LCI-PED-BMT-MUC-001
• Secondary ID: 00061628
• Status: Recruiting
• Phase: Phase 2
• Start date: February 15, 2023
• Est. completion date: August 2025

Study information

• Verified date: January 2024
• Source: Wake Forest University Health Sciences
• Contact: Sceria Jenkins, RN
• Phone: 980-442-2323
• Email: sceria.jenkins[@]atriumhealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 26 Years

Eligibility

Inclusion Criteria:

Subject must meet all the following applicable inclusion criteria to participate in this study:

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. As determined by the enrolling investigator, 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 as determined by the treating investigator

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 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

Related Conditions & MeSH terms

• Mucositis
• Oral Mucositis
• Stomatitis

Intervention

Drug:
• Virgin Coconut Oil
Standard of care with the addition of virgin coconut oil mouth rinse

Locations

Country	Name	City	State
United States	Atrium Health Levine Children's Hospital	Charlotte	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Oral Rinse Utilization	Reported as a percent of utilization	Day 45
Primary	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	Average Daily Caloric Intake	Oral intake will be calculated quantitatively for each subject during the on-treatment period.	Day 45
Secondary	Total Parenteral Nutrition (TPN)	TPN or hyperalimentation will be calculated quantitatively for each subject as the proportion of days during the on-treatment period that aggressive nutrition support was utilized.	Day 45
Secondary	Opioid Use	Daily opioid use will be calculated quantitatively for each subject in terms of their average Morphine Equivalent Daily Dose (MEDD)	Day 45
Secondary	Time to CTCAE Mucositis Grade > 2	The duration of time (in days) from the initiation of study treatment until the day of the first occurrence of a CTCAE mucositis grade exceeding 2. The CTCAE mucositis grade is a 5-point ordered-categorical scale ranging from 1 (asymptomatic or mild symptoms) to 5 (death). For subjects who do not report a grade exceeding 2, time to CTCAE mucositis grade >2 will be censored at the date of the last completed CTCAE evaluation.	Day 45
Secondary	Daily Incidence of Optional Mouth Rinses	Proportion of days during the on-treatment period that optional oral rinse was used.	Day 45
Secondary	Incidence and type of oral viral infections	Incidence and type of oral viral infections	Day 45
Secondary	Length of Hospitalization	Length of stay will be calculated for each subject as the number of days from admission date to discharge date +1.	Day 45
Secondary	Days to Absolute Neutrophil Count (ANC) Engraftment	Days to engraftment will be calculated for each subject as the number of days from Hematopoietic Stem Cell Transplantation (HSCT) to ANC recovery per Center for International Blood and Marrow Transplantation Research (CIBMTR) definition	Day 45