Clinical trial NCT05441813: 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
Overall status: RECRUITING
Phase: PHASE2
Conditions: Oral Mucositis
Keywords: Prevention
Virgin Coconut Oil
Mouth Rinse
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2022-07-01
Enrollment: 60
Sex: ALL
Minimum age (years): 7
Maximum age (years): 26
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

Eligibility criteria: 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

Primary outcomes:
measure: Severity of Mucositis
timeFrame: Day 45
Secondary outcomes:
measure: Average Daily Caloric Intake
timeFrame: Day 45
measure: Total Parenteral Nutrition (TPN)
timeFrame: Day 45
measure: Opioid Use
timeFrame: Day 45
measure: Time to CTCAE Mucositis Grade > 2
timeFrame: Day 45
measure: Daily Incidence of Optional Mouth Rinses
timeFrame: Day 45
measure: Incidence and type of oral viral infections
timeFrame: Day 45
measure: Length of Hospitalization
timeFrame: Day 45
measure: Days to Absolute Neutrophil Count (ANC) Engraftment
timeFrame: Day 45
Other outcomes:
measure: Oral Rinse Utilization
timeFrame: Day 45
Locations:
city: Charlotte
country: United States
facility: Atrium Health Levine Children's Hospital
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Courtney Huddle, MSN, RDN, CSPCC, LDN
role: PRINCIPAL_INVESTIGATOR
References: