A Randomized, Open-label Study of Coconut Oil Mouth Rinse for Prophylaxis of Severe Oral Mucositis in Pediatric Patients Receiving Myeloablative Conditioning Regimens
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Severity of Mucositis
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 26 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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
排除标准
- •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 the institutional SOP, prior to admission with a plan to continue use during admission
- •Patient has undergone HSCT within the last 90 days prior to admission
研究组 & 干预措施
Standard of Care
Arm B: Standard of care
Standard of care + virgin coconut oil
Arm A: Standard of care + virgin coconut oil
干预措施: Virgin Coconut Oil (Drug)
结局指标
主要结局
Severity of Mucositis
时间窗: 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.
次要结局
- Average Daily Caloric Intake(Day 45)
- Opioid Use(Day 45)
- Length of Hospitalization(Day 45)
- Days to Absolute Neutrophil Count (ANC) Engraftment(Day 45)
- Total Parenteral Nutrition (TPN)(Day 45)
- Time to CTCAE Mucositis Grade > 2(Day 45)
- Daily Incidence of Optional Mouth Rinses(Day 45)
- Incidence and type of oral viral infections(Day 45)