This phase II clinical trial compares the addition of virgin coconut oil (VCO) mouth rinse to standard of care (SOC) oral rinses to SOC oral rinses alone at preventing inflammation of the mouth tissue (oral mucositis) in pediatric patients receiving myeloablative conditioning regimens. Myeloablative conditioning regimens are treatments used to prepare patients for stem cell transplantation, which is when a person receives stem cells that make blood cells. Conditioning regimens may include chemotherapy, monoclonal antibody therapy, or radiation to the entire body. These conditioning regimens help make room in the bone marrow for new blood stem cells to grow and helps prevent the body from rejecting the transplanted cells, as well as helping to kill cancer cells in the body. A common complication of myeloablative conditioning regimens is oral mucositis which leads to sores and irritation in the mouth. SOC oral rinses include normal saline, Benadryl (diphenhydramine), Mylanta, lidocaine, or other combinations. VCO mouth rinse has potential anti-inflammatory, anti-microbial and antioxidant activities that may prevent inflammation of the mucosal membranes in the mouth. Using VCO mouth rinse with SOC oral rinses may be better than SOC oral rinses alone at preventing oral mucositis in pediatric patients receiving myeloablative conditioning regimens.
Additional locations may be listed on ClinicalTrials.gov for NCT05441813.
Locations matching your search criteria
United States
North Carolina
Charlotte
Carolinas Medical Center/Levine Cancer InstituteStatus: Active
Contact: Courtney Huddle
Phone: 704-446-2496
PRIMARY OBJECTIVE:
I. To evaluate the severity of oral mucositis in subjects receiving standard of care with the addition of VCO mouth rinses (Arm A) to the standard of care (Arm B) for the prevention of severe oral mucositis in pediatric patients undergoing myeloablative conditioning regimens in preparation for hematopoietic stem cell transplantation (HSCT).
SECONDARY OBJECTIVE:
I. Comparisons between the two arms will include the following:
Ia. Oral intake;
Ib. Use of parenteral nutrition intervention;
Ic. Opioid use;
Id. Time to Common Terminology Criteria for Adverse Events (CTCAE) mucositis grade > 2;
Ie. Daily incidence of optional mouth rinses allowed by standard of care practice (SOP) guidelines;
If. Incidence and type of oral viral infections (herpes simplex virus), systemic fungal and bacterial infections;
Ig. Length of hospitalization;
Ih. Days to absolute neutrophil count (ANC) engraftment.
SAFETY OBJECTIVES:
I. To summarize adherence to oral rinse administration in terms of utilization and utilization as a percent of intended utilization.
II. To summarize the rates of potential side effects related to each oral regimen, including oral pain, allergic reactions, dry mouth, or dysgeusia.
EXPLORATORY OBJECTIVE:
I. To evaluate within-participant differences in oral mucositis area under the curve (AUC) for participants randomized to Arm B who subsequently cross-over to Arm A.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients swish VCO mouth rinse over 30-60 seconds and then spit out the solution 15-30 minutes prior to each meal, 3 times per day, and receive SOC oral rinses for 45 days in the absence of unacceptable toxicity.
ARM B: Patients receive SOC oral rinses for 45 days in the absence of unacceptable toxicity. Patients with mucositis grade 3 or higher may cross over to arm A.
After completion of study treatment, patients are followed up at 30 days from last study treatment.
Trial PhasePhase II
Trial Typesupportive care
Lead OrganizationWake Forest University Health Sciences
Principal InvestigatorCourtney Huddle
