NCT02381405终止不适用
A Randomized Open Label Study Evaluating a Proprietary Amino Acid Mixture (Enterade®)- for Maintaining Bowel Regularity in Patients With GI Toxicity From Any Combination of Therapy Including Tyrosine Kinase Inhibitors (TKI)
GenesisCare USA1 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2015年2月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Patient reported gastrointestinal (GI) symptoms using EPIC
研究概览
简要总结
This is an open label, randomized investigation of a proprietary blend of amino acids, called Enterade®, and its effect on irregularity (diarrhea) caused by radiation therapy and/or chemotherapy including TKI*. Subjects will be randomized to receive Enterade® or continue standard of care. Two patients will be enrolled on the treatment arm for each patient on the control arm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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 with any combination of therapies including radiation therapy alone, chemotherapy alone, TKI alone, or any combination are eligible.
- •This includes patients with therapies including Xeloda (capecitabine), Camptosar (irinotecan) or 5-FU (fluorouracil) with cancer.
- •Patients who have been diagnosed with a CID CTCAE toxicity of grade 3 or higher
- •Patients must be at least 18 years of age.
- •ECOG performance status 0-
- •Patients must have diarrhea symptoms, judged secondary to the systemic therapy, combined systemic therapy, and/or radiation, and must be requiring loperamide or similar (Imodium®) for symptom management. For the purposes of this study, diarrhea will be defined as three or more loose or liquid stools per day or loose watery stool (greater volume of stool) that occur more frequently than usual and lasting for more than three days.
排除标准
- •ECOG performance status 3 or greater.
- •Pregnant and/or breast-feeding women
- •Pre-menopausal subjects as well as subjects with ovarian radiation or concomitant treatment with an LH-RH agonist/antagonist must have a negative pregnancy test and agree to use an adequate method of contraception as recommended by their treating physicians
- •Post-menopausal status is defined either by:
- •age ≥55 years and one year or more of amenorrhea,
- •age <55 years and one year or more of amenorrhea with an estradiol assay <20 pg/mL
- •bilateral oophorectomy
- •CID CTCAE grade 1 or 2 (not requiring Loperamide or similar)
研究组 & 干预措施
A
Active Comparator
Enterade beverage
干预措施: Enterade beverage (Dietary Supplement)
B
No Intervention
Standard of care
结局指标
主要结局
Patient reported gastrointestinal (GI) symptoms using EPIC
时间窗: 12 Days
次要结局
未报告次要终点
研究者
研究点 (1)
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