Feasibility of Implementing Sustained Oral Fiber Supplementation for Patients Undergoing Treatment for Hematological Malignancies
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Study participation rates
研究概览
简要总结
This clinical trial examines sustained oral fiber supplementation for patients undergoing treatment for hematological malignancies. Patients undergoing cancer treatment, including donor stem cell transplantation often develop oral and gastrointestinal damage from chemotherapy, radiotherapy, or graft-versus-host disease. Oral fiber nutrition support may improve overall nutrition, support a normal gut microbiome (bacteria that live in the gut) and/or improve gut function in patients undergoing treatment for hematological malignancies.
详细描述
OUTLINE:
Current study design: Patients receive fiber supplementation orally (PO) or enterally starting 14 to 5 days prior to standard of care treatment and continuing until day 42 post-treatment. Patients who are not able to receive sufficient nutrition by mouth may receive parenteral nutrition or enteral nutrition by feeding tube from the hospital. Patients may undergo blood sample collection throughout the study.
Previous study design: Before this study was amended in January 2024, patients were randomized to 1 of 2 arms.
Previous Arm I: Patients received enteral nutrition via nasoenteric feeding tube starting on day 1 until hospital discharge.
Previous Arm II: Patients received standard of care nutritional support.
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
- •Able to provide written informed consent prior to initiation of any study procedures
- •Any diagnosed hematological malignancy
- •At least 18 years of age
- •Planned treatment at Fred Hutchinson Cancer Center and/or University of Washington Medical Center
排除标准
- •Major psychiatric diagnosis that impairs cognitive functioning or is not controlled at the time of the approach, as judged by the patient's medical team
- •Pregnant or breastfeeding. Pregnancy test is obtained as part of pre-transplant evaluation in women of child-bearing potential at arrival to transplant and again within 7 days of conditioning and will be confirmed as negative by review of the chart
研究组 & 干预措施
Arm I (enteral nutrition) [Discontinued in January 2024]
Patients receive enteral nutrition via nasoenteric feeding tube starting on day 1 until hospital discharge.
干预措施: Survey Administration (Other)
Arm II (standard of care) [Discontinued in January 2024]
Patients receive standard of care nutritional support.
干预措施: Survey Administration (Other)
Arm I (enteral nutrition) [Discontinued in January 2024]
Patients receive enteral nutrition via nasoenteric feeding tube starting on day 1 until hospital discharge.
干预措施: Kate Farms 1.0 (Dietary Supplement)
Supportive care (Fiber) [Current study activity]
Patients receive fiber supplementation PO or enterally starting 14 to 5 days prior to standard of care treatment and continuing until day 42 post-treatment. Stool will be collected at different time points throughout the study. Patients may also undergo blood sample collection throughout the study.
干预措施: Biospecimen Collection (Procedure)
Arm II (standard of care) [Discontinued in January 2024]
Patients receive standard of care nutritional support.
干预措施: Standard of Care Nutritional Support (Dietary Supplement)
Supportive care (Fiber) [Current study activity]
Patients receive fiber supplementation PO or enterally starting 14 to 5 days prior to standard of care treatment and continuing until day 42 post-treatment. Stool will be collected at different time points throughout the study. Patients may also undergo blood sample collection throughout the study.
干预措施: Survey Administration (Other)
Supportive care (Fiber) [Current study activity]
Patients receive fiber supplementation PO or enterally starting 14 to 5 days prior to standard of care treatment and continuing until day 42 post-treatment. Stool will be collected at different time points throughout the study. Patients may also undergo blood sample collection throughout the study.
干预措施: Dietary Supplement (Dietary Supplement)
Supportive care (Fiber) [Current study activity]
Patients receive fiber supplementation PO or enterally starting 14 to 5 days prior to standard of care treatment and continuing until day 42 post-treatment. Stool will be collected at different time points throughout the study. Patients may also undergo blood sample collection throughout the study.
干预措施: Electronic Health Record Review (Other)
Supportive care (Fiber) [Current study activity]
Patients receive fiber supplementation PO or enterally starting 14 to 5 days prior to standard of care treatment and continuing until day 42 post-treatment. Stool will be collected at different time points throughout the study. Patients may also undergo blood sample collection throughout the study.
干预措施: Fiber and Dietary Assessments (Other)
结局指标
主要结局
Study participation rates
时间窗: Assessed at consenting
The proportion of eligible patients who consent to enroll in the study will be computed based on the number approached and estimated with 95% confidence intervals.
次要结局
- Level of comfort/distress attributed to initiating and maintaining oral fiber intake(Up to 90 days following transplant)
- Incidence of adverse events(Up to 90 days following transplant)
- Number of days receiving at least 10 grams of fiber(Up to 90 days following transplant)
- Number of days receiving at least 25 grams of fiber(Up to 90 days following transplant)
- Tolerance of initiating and maintaining oral fiber intake(Up to 90 days following transplant)
- Number of days receiving at least 10 grams of fiber(Up to 90 days following treatment)
- Number of days receiving any amount of fiber(Up to 90 days following treatment)
- Number of days receiving at least 25 grams of fiber(Up to 90 days following treatment)
- Tolerance of initiating and maintaining oral fiber intake(Up to 90 days following treatment)
- Level of comfort/distress attributed to initiating and maintaining oral fiber intake(Up to 90 days following treatment)
- Incidence of adverse events(Up to 90 days following treatment)