A Phase 2 Study Evaluating a Proprietary Amino Acid Based Medical Food (Enterade®) in Patients With Quality of Life Limiting Diarrhea Due to Carcinoid Syndrome and Other Neuroendocrine Tumors (NET).
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Effect of amino acids in tightening the intestinal barrier and protecting from antigenic translocation by evaluating plasma circulating cytokine levels in peripheral blood sample.
研究概览
简要总结
Primary Objective:
To assess how an amino acid based medical food (Enterade®) helps maintain the intestine's ability to absorb and retain fluids, leading to a reduction in diarrhea due to Neuroendocrine Tumors (NET) and/or Carcinoid Syndrome. This improvement in the absorption will be assessed in part by evaluating changes in average daily stool frequency from baseline in patients receiving Enterade®. Each subject serves as his or her own control.
Secondary Objectives:
- To assess subject reported health-related quality of life in subjects before and after compound administration.
- To characterize the side effect profile and tolerability of Enterade® as measured by the number of total 8-oz Enterade® bottles consumed throughout the trial, and average drinks per day.
- To evaluate changes in serum electrolytes before and after administration of Eenterade®.
- To assess intravenous fluid requirement and/or hospitalization for dehydration secondary to diarrhea between control observation period and active Enterade® period.
- To evaluate difference in utilization of standard-of-care anti-diarrheal medications between control observation period and Enterade® period.
- To compare subjective feeling of bloating and flatulence before and after administration of Enterade®.
- To evaluate changes in patient weight before and after administration of Enterade®.
详细描述
This prospective, phase 2 study is to assess how Enterade® will affect patient-reported quality of life and intestinal absorption in patients with Carcinoid Syndrome and Neuroendocrine Tumors. The hypothesis is that Enterade® when combined with standard supportive care will improve patient-reported quality of life and help maintain the small bowel's ability to absorb and retain fluids, possibly leading to a reduction in diarrhea frequency.
- This is a non-randomized, supportive-care study.
- Potentially eligible patients will be screened in the University of Kentucky Markey Cancer Center clinics.
- During the screening visit, immediately after signing informed consent, the participant will be given both flavors of enterade® (original vanilla and refreshing orange) to test tolerability and taste.
- Eligible subjects will be given a stool diary and will be asked to document daily stool output (frequency and consistency of stool), use of anti-diarrheal medication and gastrointestinal discomforts (bloating, cramping).
- All lab and screening tests should be completed within 2 weeks prior to registration/initiation of study.
- The study is broken into 3 distinct segments and will apply to all enrolled participants: Baseline observation (Weeks 1-4), Enterade® administration period (4 weeks), Post-Enterade® Period (4 weeks).
- After relapse of diarrhea is documented or the 4 weeks of post-Enterade® observation are completed (whatever happens first), participants will be given the option to restart Enterade® for 1 additional month.
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
- •Cohort 1: Participants must have histopathologically confirmed neuroendocrine tumor with 4 or more bowel movements per day on standard anti-diarrheal regimen (which may or may not include somatostatin analogs and telotristat), AND an elevated serum serotonin or plasma serotonin above the upper limit of normal per reference lab.
- •Cohort 2: 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 and telotristat), but are below the cut-point for serotonin elevation.
- •Age equal to or greater than 18 years old.
- •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 active clostridium difficile infection will be ineligible for this study.
- •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 12 months.
研究组 & 干预措施
NET with carcinoid syndrome
Participants with NET and carcinoid syndrome will be instructed to drink two 8 oz. bottles of Amino Acid Based Medical Food/Drink (Enterade®) per day.
干预措施: Amino Acid Based Medical Food/Drink (Dietary Supplement)
NET w/o cardinoid syndrome
Participants with NET w/o carcinoid syndrome will be instructed to drink two 8 oz. bottles of Amino Acid Based Medical Food/Drink (Enterade®) per day.
干预措施: Amino Acid Based Medical Food/Drink (Dietary Supplement)
结局指标
主要结局
Effect of amino acids in tightening the intestinal barrier and protecting from antigenic translocation by evaluating plasma circulating cytokine levels in peripheral blood sample.
时间窗: 56 days
ELISA assays will be used to assess pro-inflammatory cytokines IL-1β, IL-6 and TNFα and serum endotoxin from blood samples collected.
次要结局
- Evaluation of increased bacterial translocation and systemic inflammation.(56 days)
研究者
Lowell Anthony, MD
Principal Investigator
University of Kentucky