The Effect of Oral Supplementation and Improved Nutritional Status on Hematopoietic Stem Cell Transplant Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Change in nutritional status determined by the Patient-Generated Subjective Global Assessment (PG-SGA)
研究概览
简要总结
This clinical trial studies the use of early oral supplementation in improving nutritional status in participants undergoing hematopoietic stem cell transplant. Impaired nutritional status in participants undergoing hematopoietic stem cell transplant has been linked to decreased outcomes such as increased length of hospital stay and increased time to engraftment (an important milestone in transplant recovery). Early oral supplementation may increase nutritional status and help to promote a positive outcome in participants undergoing transplant.
详细描述
PRIMARY OBJECTIVES:
I. To determine if early oral supplementation improves nutritional status, decreases length of hospital stay, and shortens time to engraftment of hematopoietic stem cell transplant (HSCT) participants.
SECONDARY OBJECTIVES:
I. Serum albumin, serum 25-hydroxy vitamin D, and the degree of mucositis, as scored by the National Cancer Institute's Common Toxicity Criteria (NCI-CTC), a validated and widely accepted scale used for rating mucositis. The purpose of our secondary aims is to observe a potential correlation between the retrospective and prospective groups, as well as assess the need for future research based on these correlations.
OUTLINE:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergoing an autologous or reduced intensity conditioning (RIC) allogeneic HSCT
- •A serum albumin greater than or equal to 2.5 g/dL
- •Able to understand and sign consent
排除标准
- •Patients who have malabsorption problems, such as ulcerative colitis, irritable bowel syndrome, Crohn's disease, bowel surgery such as gastric bypass, and celiac disease
研究组 & 干预措施
Supportive care (Boost Plus, Pro-Stat 101)
Participants receive Boost Plus PO BID or Pro-Stat 101 PO BID beginning one week before scheduled HSCT and continuing until hospital discharge. If participants do not tolerate the Boost Plus or Pro-Stat, they receive a milkshake PO QD as an alternative.
干预措施: Boost Plus (Dietary Supplement)
Supportive care (Boost Plus, Pro-Stat 101)
Participants receive Boost Plus PO BID or Pro-Stat 101 PO BID beginning one week before scheduled HSCT and continuing until hospital discharge. If participants do not tolerate the Boost Plus or Pro-Stat, they receive a milkshake PO QD as an alternative.
干预措施: Pro-Stat 101 (Dietary Supplement)
Supportive care (Boost Plus, Pro-Stat 101)
Participants receive Boost Plus PO BID or Pro-Stat 101 PO BID beginning one week before scheduled HSCT and continuing until hospital discharge. If participants do not tolerate the Boost Plus or Pro-Stat, they receive a milkshake PO QD as an alternative.
干预措施: Milkshake (Dietary Supplement)
Supportive care (Boost Plus, Pro-Stat 101)
Participants receive Boost Plus PO BID or Pro-Stat 101 PO BID beginning one week before scheduled HSCT and continuing until hospital discharge. If participants do not tolerate the Boost Plus or Pro-Stat, they receive a milkshake PO QD as an alternative.
干预措施: daily food diaries (Other)
结局指标
主要结局
Change in nutritional status determined by the Patient-Generated Subjective Global Assessment (PG-SGA)
时间窗: Baseline to time of hospital discharge, up to 1 year
To test the improvement of nutritional status over a period of time, a linear mixed model will be fit and the PG-SGA trend will be tested.
次要结局
- Degree of mucositis(Week 2, Week 3, Week 4, up to time of hospital discharge, up to 52 weeks)
- Length of hospital stay, defined by time of admission through discharge(Up to time of hospital discharge, up to 1 year)
- Change in serum albumin(Baseline, up to time of hospital discharge, up to 1 year)
- Change in serum 25-hydroxy vitamin D(Baseline, up to time of hospital discharge, up to 1 year)
- Time to engraftment, defined by the first of three consecutive days that the absolute neutrophil count is greater than 500(Up to time of hospital discharge, up to 1 year)