A Randomized Double Blinded Trial of Topical Caphosol to Prevent Oral Mucositis in Children Undergoing Hematopoietic Stem Cell Transplantation
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 226
- 试验地点
- 35
- 主要终点
- Duration of Severe Oral Mucositis (WHO Grade 3 or 4)
研究概览
简要总结
This randomized phase III trial is studying how well Caphosol rinse works in preventing mucositis in young patients undergoing autologous or donor stem cell transplant. Supersaturated calcium phosphate (Caphosol) rinse may be able to prevent mucositis, or mouth sores, in patients undergoing stem cell transplant.
详细描述
PRIMARY OBJECTIVES:
I. To determine if topically administered supersaturated calcium phosphate (Caphosol), rinsed orally four times daily at the initiation of conditioning for hematopoietic stem cell transplantation (HSCT), reduces oral mucositis as demonstrated by a decrease in duration of severe oral mucositis (World Health Organization [WHO] grade 3 or 4), compared to placebo.
SECONDARY OBJECTIVES:
I. To determine whether Caphosol administration, when compared to placebo, reduces oral mucositis as demonstrated by a decrease in incidence of severe oral mucositis (WHO grade 3 or 4); severity of mucositis according to mouth pain categorical rating scale and Oral Mucositis Daily Questionnaire (OMDQ); incidence, total dose, and duration of parenteral opioid analgesic use (morphine equivalents); and incidence and duration of total parenteral nutrition (TPN) administration.
II. To determine whether Caphosol administration, when compared to placebo, reduces the incidence of febrile neutropenia and invasive bacterial infections.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 4 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing myeloablative autologous or allogeneic hematopoietic stem cell transplantation (HSCT) for any indication
- •One or more of the following donor stem cell sources (autologous or allogeneic):
- •Bone marrow
- •Placental blood (umbilical cord blood)
- •Cytokine-mobilized peripheral blood
- •Patients eligible for allogeneic HSCT must have one of the following types of donor stem cells:
- •Human leukocyte antigen (HLA)-matched sibling or parent
- •Partially matched family donor (mismatched for a single HLA locus [Class I])
- •Fully matched unrelated marrow or peripheral blood stem cell donor
- •HLA-matched or partially mismatched (at least 4 of 6 match) cord blood (Class I or II)
- •Patients expecting to receive any type of myeloablative HSCT conditioning regimen are eligible
- •No non-myeloablative or reduced-intensity conditioning regimens
- •Eligible patients must not have received palifermin within 30 days prior to enrollment
- •Eligible patients must not have received prior treatment with Caphosol
排除标准
- •Females of childbearing potential must have a negative pregnancy test; patients must agree to use an effective birth control method; lactating patients must agree not to nurse a child while on this trial
研究组 & 干预措施
Arm I (placebo)
Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.
干预措施: placebo (Other)
Arm I (placebo)
Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.
干预措施: questionnaire administration (Other)
Arm I (placebo)
Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.
干预措施: quality-of-life assessment (Procedure)
Arm II (supersaturated calcium phosphate rinse)
Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.
干预措施: supersaturated calcium phosphate rinse (Drug)
Arm II (supersaturated calcium phosphate rinse)
Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.
干预措施: questionnaire administration (Other)
Arm II (supersaturated calcium phosphate rinse)
Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.
干预措施: quality-of-life assessment (Procedure)
结局指标
主要结局
Duration of Severe Oral Mucositis (WHO Grade 3 or 4)
时间窗: Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.
Mean days of severe (WHO Grade 3 or 4) Mucositis.
次要结局
- Incidence of Severe Oral Mucositis(Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.)
- Oral Mucositis Daily Questionnaire (OMDQ)(Day -1 (day prior to stem cell infusion) to Day 20 following transplantation)
- Incidence of Parenteral Opioid Analgesic Use (Morphine Equivalents).(Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.)
- Duration of Parenteral Opioid Analgesic Use (Morphine Equivalents).(Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.)
- Total Dose of Parenteral Opioid Analgesic Used (Morphine Equivalents).(Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.)
- Incidence of Total Parenteral Nutrition (TPN) Administration.(Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.)
- Duration of Total Parenteral Nutrition (TPN) Administration.(Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.)
- Incidence of Febrile Neutropenia(Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.)
- Incidence of Invasive Bacterial Infections(Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.)
- Severity of Mucositis(Day -1 (day prior to stem cell infusion) to Day 20 following transplantation)