Back to resultsCoconut Oil to Prevent Mouth Sores in Pediatric Patients Receiving High Dose Chemotherapy
Primary Purpose
Oral Mucositis
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Virgin Coconut Oil
Sponsored by
About this trial
This is an interventional supportive care trial for Oral Mucositis focused on measuring Prevention, Virgin Coconut Oil, Mouth Rinse
Eligibility Criteria
Inclusion Criteria:
Subject must meet all the following applicable inclusion criteria to participate in this study:
- 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
- As determined by the enrolling physician, 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 as determined by the treating investigator
Exclusion Criteria:
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 SOP, prior to admission with a plan to continue use during admission
- Patient has undergone HSCT within the last 90 days prior to admission
Sites / Locations
- Atrium Health Levine Children's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Standard of care + virgin coconut oil
Standard of Care
Arm Description
Arm A: Standard of care + virgin coconut oil
Arm B: Standard of care
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Average Daily Caloric Intake
Oral intake will be calculated quantitatively for each subject during the on-treatment period.
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.
Opioid Use
Daily opioid use will be calculated quantitatively for each subject in terms of their average Morphine Equivalent Daily Dose (MEDD)
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.
Daily Incidence of Optional Mouth Rinses
Proportion of days during the on-treatment period that optional oral rinse was used.
Incidence and type of oral viral infections
Incidence and type of oral viral infections
Length of Hospitalization
Length of stay will be calculated for each subject as the number of days from admission date to discharge date +1.
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
Full Information
NCT ID
NCT05441813
First Posted
June 27, 2022
Last Updated
July 5, 2023
Sponsor
Wake Forest University Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT05441813
Brief Title
Coconut Oil to Prevent Mouth Sores in Pediatric Patients Receiving High Dose Chemotherapy
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 15, 2023 (Actual)
Primary Completion Date
August 2025 (Anticipated)
Study Completion Date
August 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Mucositis
Keywords
Prevention, Virgin Coconut Oil, Mouth Rinse
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard of care + virgin coconut oil
Arm Type
Experimental
Arm Description
Arm A: Standard of care + virgin coconut oil
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
Arm B: Standard of care
Intervention Type
Drug
Intervention Name(s)
Virgin Coconut Oil
Intervention Description
Standard of care with the addition of virgin coconut oil mouth rinse
Primary Outcome Measure Information:
Title
Severity of Mucositis
Description
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.
Time Frame
Day 45
Secondary Outcome Measure Information:
Title
Average Daily Caloric Intake
Description
Oral intake will be calculated quantitatively for each subject during the on-treatment period.
Time Frame
Day 45
Title
Total Parenteral Nutrition (TPN)
Description
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.
Time Frame
Day 45
Title
Opioid Use
Description
Daily opioid use will be calculated quantitatively for each subject in terms of their average Morphine Equivalent Daily Dose (MEDD)
Time Frame
Day 45
Title
Time to CTCAE Mucositis Grade > 2
Description
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.
Time Frame
Day 45
Title
Daily Incidence of Optional Mouth Rinses
Description
Proportion of days during the on-treatment period that optional oral rinse was used.
Time Frame
Day 45
Title
Incidence and type of oral viral infections
Description
Incidence and type of oral viral infections
Time Frame
Day 45
Title
Length of Hospitalization
Description
Length of stay will be calculated for each subject as the number of days from admission date to discharge date +1.
Time Frame
Day 45
Title
Days to Absolute Neutrophil Count (ANC) Engraftment
Description
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
Time Frame
Day 45
Other Pre-specified Outcome Measures:
Title
Oral Rinse Utilization
Description
Reported as a percent of utilization
Time Frame
Day 45
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
26 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject must meet all the following applicable inclusion criteria to participate in this study:
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
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
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:
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 SOP, prior to admission with a plan to continue use during admission
Patient has undergone HSCT within the last 90 days prior to admission
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sceria Jenkins, RN
Phone
980-442-2323
Email
sceria.jenkins@atriumhealth.org
First Name & Middle Initial & Last Name or Official Title & Degree
Marithza Amaya
Phone
980-442-0530
Email
marirthza.amaya@atriumhealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Courtney Huddle, MSN, RDN, CSPCC, LDN
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Atrium Health Levine Children's Hospital
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Courtney Huddle, MSN, RDN, CSPCC, LDN
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Coconut Oil to Prevent Mouth Sores in Pediatric Patients Receiving High Dose Chemotherapy
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