Gluten Free Diet for AML Patients Undergoing Induction Chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Rate of compliance with GFD assessed using daily food intake diary
研究概览
简要总结
This randomized phase II trial studies how well a gluten free diet works in diminishing side effects in patients with acute myeloid leukemia undergoing induction chemotherapy. A gluten free diet may result in less intestinal side effects and blood infections during the induction chemotherapy compared to a standard diet.
详细描述
PRIMARY OBJECTIVES:
I. To determine if a gluten free diet (GFD) modulates the rate and severity of bacteremia and gastrointestinal toxicity (measured by total parenteral nutrition [TPN] or nothing by mouth [NPO] order) in patients undergoing standard acute myeloid leukemia (AML) induction chemotherapy.
SECONDARY OBJECTIVES:
I. To determine the tolerance of, and compliance with, a GFD in patients undergoing standard AML induction chemotherapy.
OUTLINE: Patients are randomized to 1 of 2 groups.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing AML induction chemotherapy with an anthracycline + cytarabine-based chemotherapy regimen
- •No history of celiac disease or non-celiac gluten sensitivity
- •No grade 3 or 4 gastrointestinal (GI) toxicity at time of initial screening
- •No documented bacteremia at time of initial screening
- •Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2 at time of initial screening
排除标准
- •Pregnant women
研究组 & 干预措施
Group I (GFD)
Patients receive GFD prepared by the hospital per dietary/nutrition pharmacy standards from the initiation of induction chemotherapy until hospital discharge (approximately 30 days). Patients also complete a daily food intake diary. A stool sample is collected from patients at baseline, day 14, and on the day of hospital discharge for gut microbiome analysis.
干预措施: Biospecimen Collection (Procedure)
Group I (GFD)
Patients receive GFD prepared by the hospital per dietary/nutrition pharmacy standards from the initiation of induction chemotherapy until hospital discharge (approximately 30 days). Patients also complete a daily food intake diary. A stool sample is collected from patients at baseline, day 14, and on the day of hospital discharge for gut microbiome analysis.
干预措施: Dietary Intervention (Other)
Group I (GFD)
Patients receive GFD prepared by the hospital per dietary/nutrition pharmacy standards from the initiation of induction chemotherapy until hospital discharge (approximately 30 days). Patients also complete a daily food intake diary. A stool sample is collected from patients at baseline, day 14, and on the day of hospital discharge for gut microbiome analysis.
干预措施: Laboratory Biomarker Analysis (Other)
Group II (standard diet)
Patients receive a standard diet for from the initiation of induction chemotherapy until hospital discharge (approximately 30 days). Patients also complete a daily food intake diary. A stool sample is collected from patients at baseline, day 14, and on the day of hospital discharge for gut microbiome analysis.
干预措施: Best Practice (Other)
Group II (standard diet)
Patients receive a standard diet for from the initiation of induction chemotherapy until hospital discharge (approximately 30 days). Patients also complete a daily food intake diary. A stool sample is collected from patients at baseline, day 14, and on the day of hospital discharge for gut microbiome analysis.
干预措施: Biospecimen Collection (Procedure)
Group II (standard diet)
Patients receive a standard diet for from the initiation of induction chemotherapy until hospital discharge (approximately 30 days). Patients also complete a daily food intake diary. A stool sample is collected from patients at baseline, day 14, and on the day of hospital discharge for gut microbiome analysis.
干预措施: Laboratory Biomarker Analysis (Other)
结局指标
主要结局
Rate of compliance with GFD assessed using daily food intake diary
时间窗: Up to 30 days
Adherence to diet will be recorded in a food diary. Compliance will be defined as \> 67% of meals being gluten free.
Rate and severity of GI symptoms during AML induction therapy
时间窗: Up to 30 days
To determine what the severity is if GI symptoms develops
Rate and severity of bacteremia with enteric organisms during AML induction therapy assessed using stool samples
时间窗: Up to 30 days
To determine how often patients develop bacteremia during AML induction therapy
次要结局
未报告次要终点