NCT04073017终止不适用
Proprietary Amino Acid-Based Medical Food (Enterade) in Carcinoid Syndrome and Non-Carcinoid Syndrome Neuroendocrine Tumor Patients With Quality of Life Limiting Bowel Frequency
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Change in bowel movement frequency
研究概览
简要总结
This is an open-label phase II basket study evaluating the ability of enterade® to reduce bowel frequency in neuroendocrine tumor (NET) patients with carcinoid syndrome and non-carcinoid syndrome.
详细描述
Primary Objective:
- To assess the ability of enterade to reduce bowel movement frequency in NET patients with and without carcinoid syndrome.
Secondary Objectives:
- To assess subject-reported health-related quality of life measures in subjects before and after compound administration.
- To characterize the side effect profile and tolerability of the compound as measured by the number of total 8-oz enterade® bottles consumed throughout the trial.
- To evaluate changes in serum electrolytes before and after administration of the compound.
- To assess differences in intravenous fluid requirement and/or hospitalizations for dehydration in patients between observation period and active enterade® period.
- To evaluate differences in utilization of standard-of-care anti-diarrheal medications in patients between observation period and enterade® period.
- To compare subjective bloating and flatulence in patients before and after administration of the compound.
- To evaluate changes in patient weight before and after administration of the compound.
Exploratory Objectives:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Carcinoid syndrome:
- •Participants must have histopathologically confirmed neuroendocrine tumor with 4 or more bowel movements per day on standard anti-diarrheal regimen (which includes somatostatin analogs and/or Telotristat Ethyl). Additionally, a plasma 5-HIAA, or a urine 24-hour 5-HIAA or plasma secretory hormone levels (VIP, gastrin) above the upper limit of normal per reference lab. Patients may be grouped into this cohort based on a previous plasma 5-HIAA level though the final cohort determination will be made based upon the 5-HIAA level drawn during screening.
- •Non-Carcinoid Syndrome:
- •Participants who have histopathologically confirmed neuroendocrine tumor and have 4 or more bowel movements per day on standard anti-diarrheal regimen (which may or may not include somatostatin analogs), but do not have elevated results for one of the following: plasma 5-HIAA, or 24-hour urine 5-HIAA or other plasma secretory hormone levels (VIP, gastrin) above the upper limit of normal per reference lab. Patients may be grouped into this cohort based on a previous plasma 5-HIAA level though the final cohort determination will be made based upon the 5-HIAA level drawn during screening
- •ECOG performance status ≤ 2 (Karnofsky ≥60%)
- •Ability to tolerate thin liquids by mouth at the time of enrollment.
- •Ability to understand and the willingness to sign a written informed consent document.
- •Subject who are willing to take enterade® as instructed will be eligible.
排除标准
- •Known allergy to Stevia.
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active
- •Clostridium difficile infection or history of Clostridium difficile infection.
- •Participants with a history of inflammatory bowel disease, irritable bowel syndrome, bariatric surgery and/or Celiac disease.
- •Participants with psychiatric illness/social situations that would limit compliance with study requirements.
- •Patients who have had enterade® within the past 3 months.
- •Pregnant or breastfeeding women. The safety of enterade® has not been validated in this patient population.
结局指标
主要结局
Change in bowel movement frequency
时间窗: At 8 weeks
Changes in number of average daily bowel movements from baseline
次要结局
- Tolerability of enterade®: number of enterade® drinks consumed(At 8 weeks)
- Change in serum electrolytes (Chloride)(At 8 weeks)
- Change in serum electrolytes (Phosphorous)(At 8 weeks)
- Differences in bloating(At 8 weeks)
- Health-Related Quality of Life: Functional Assessment of Chronic Illness Therapy for Patients with Diarrhea (FACIT-D) version 4.0(At 8 weeks)
- Incidents adverse events(At 8 weeks)
- Differences in use of standard-of-care anti-diarrhea medications(At 8 weeks)
- Changes in weight(At 8 weeks)
- Change in serum electrolytes (Sodium)(At 8 weeks)
- Change in serum electrolytes (Potassium)(At 8 weeks)
- Change in serum electrolytes (Magnesium)(At 8 weeks)
- Differences in intravenous fluid requirements(At 8 weeks)
- Differences in flatulence(At 8 weeks)
研究者
Satya Das
Sponsor Investigator
Vanderbilt-Ingram Cancer Center
研究点 (2)
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