A Phase II Randomized Trial of Enteral Nutrition Versus Standard of Care in Allogeneic Hematopoietic Stem Cell Transplantation
概览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Incidence of Stage 3-4 Acute GVHD of Lower Gut
概览
简要总结
This is a randomized controlled phase II trial which will enroll 112 patients with a diagnosis of a blood cancer or a serious blood disorder who plan to undergo an allogenic hematopoietic stem cell transplant using any conditioning regimen or graft source. Eligible patients will be randomized to receive standard of care (e.g., initiation of supplemental nutrition when oral intake declines) versus enteral nutrition via enteral feeding tube starting on day +1 post-transplant for at least 7 days, usually until engraftment. The primary endpoint will be cumulative incidence of stage 3-4 acute GVHD of the lower gut by day +100 post-transplant, whereas secondary endpoints will be stage 2-4 acute GVHD of the lower gut by day +100, grade 2-4 acute GVHD, weight loss and changes in lean muscle mass, changes in physical function, health-related quality of life, length of transplant hospital stay, and time to platelet and neutrophil engraftment. Assessments will include acute GVHD assessments and grading, Activities of Daily Living (ADL), Instrumental Activities of Daily Living (IADL), Fried Frailty Index, and Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT).
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of a hematological condition or serious blood disorder
- •Patient planned for an allogeneic hematopoietic stem cell transplant
- •Any conditioning regimen or graft source
排除标准
- •Uncorrected anatomical deformity of the nose, nasopharynx, esophagus, or stomach that could prevent proper placement of a nasogastric tube.
- •Chronic gastrointestinal conditions causing malabsorption or need for nutritional supplementation, e.g., celiac disease, short gut syndrome, chronic use of total parental nutrition or enteral nutrition for 3 or more months. Uncorrected anatomical deformity may include any known significant deviated nasal septum, large nasal polyps or other masses, or nasal or oropharyngeal trauma.
研究组 & 干预措施
The control (initiation of supplemental enteral or parenteral nutrition as clinically indicated)
干预措施: Enteral Nutrition (Dietary Supplement)
The study group (enteral nutrition starting on day +1)
干预措施: Enteral Nutrition (Dietary Supplement)
结局指标
主要结局
Incidence of Stage 3-4 Acute GVHD of Lower Gut
时间窗: 100 Days post- transplant
Cumulative incidence will be calculated as the time to stage 3-4 acute GVHD of the lower gut for each of the study arms.
次要结局
- Incidence of Stage 2-4 Acute GVHD of Lower Gut(100 Days post- transplant)
- Percent change in weight(Day +30 and Day +100 post-transplant)
- Percent change in lean body mass(Baseline and Day +30 post-transplant)
- Health-Related Quality of Life (HRQoL)(Baseline and Day +100 post-transplant)
- Transplant hospital stay(Up to approximately 30 Days Post Transplant)
- Platelet and neutrophil engraftment(Aproximately14 days post-transplant)
- Functional status and physical performance(Day +30, and Day +100 post-transplant)
- Functional status and physical performance Instrumental Activities of Daily Living (IADL)(Day +30, and Day +100 post-transplant)
- Functional status and physical performance Activities of Daily Living (ADL)(Day +30, and Day +100 post-transplant)