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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Oral Mucositis

Intervention / Treatment
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* Drug: Virgin Coconut Oil


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 26 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standard of care + virgin coconut oil<br>Arm A: Standard of care + virgin coconut oil | Drug: Virgin Coconut Oil<br>* Standard of care with the addition of virgin coconut oil mouth rinse<br>|
| No Intervention: Standard of Care<br>Arm B: Standard of care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Daily Caloric Intake | Oral intake will be calculated quantitatively for each subject during the on-treatment period. | Day 45 | 
| 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 | 
| Opioid Use | Daily opioid use will be calculated quantitatively for each subject in terms of their average Morphine Equivalent Daily Dose (MEDD) | Day 45 | 
| 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 | 
| Daily Incidence of Optional Mouth Rinses | Proportion of days during the on-treatment period that optional oral rinse was used. | Day 45 | 
| Incidence and type of oral viral infections | Incidence and type of oral viral infections | Day 45 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prevention, Virgin Coconut Oil, Mouth Rinse