Oral Mucositis
Conditions
Keywords
Prevention, Virgin Coconut Oil, Mouth Rinse
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
Interventions
Standard of care with the addition of virgin coconut oil mouth rinse
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Years to 26 Years
Healthy volunteers
No
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. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Severity of Mucositis | Day 45 | 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
| Measure | Time frame | Description |
|---|---|---|
| Average Daily Caloric Intake | Day 45 | Oral intake will be calculated quantitatively for each subject during the on-treatment period. |
| Total Parenteral Nutrition (TPN) | Day 45 | 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 | Day 45 | 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 | Day 45 | 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. |
| Incidence and type of oral viral infections | Day 45 | Incidence and type of oral viral infections |
| Length of Hospitalization | Day 45 | 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 | Day 45 | 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 |
| Daily Incidence of Optional Mouth Rinses | Day 45 | Proportion of days during the on-treatment period that optional oral rinse was used. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Oral Rinse Utilization | Day 45 | Reported as a percent of utilization |
Countries
United States
Contacts
Primary ContactSceria Jenkins, RN
Backup ContactMarithza Amaya
Outcome results
None listed