A Phase 2 Randomized Controlled Trial of Epigallocatechin-3-Gallate (EGCG) on Frailty and Inflammation in Older Survivors of Cancer
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- Change of physical frailty measured using the Short Physical Performance Battery (SPPB) in patients in the EGCG arm compared to placebo; change in SPPB scores from baseline to 12 weeks.
研究概览
简要总结
This study is a two-arm placebo controlled randomized clinical trial, to assess the effect of a 12-week EGCG intervention on physical frailty compared to placebo in pre-frail older cancer survivors.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be age 65 or over.
- •Be diagnosed with stage I-III Cancer
- •Have completed curative intent treatment ≤10 years prior to screening Patients on the following endocrine therapies are allowed to enroll (Anastrozole,Leuprolide acetate, and Bicalutamide)
- •Have a Fried's Frailty Score (FFS) of ≥ 1
- •Able to provide informed consent
排除标准
- •Have chemotherapy or other systemic cancer treatment planned to occur during the study period.
- •Have abnormal liver function tests (ALT, AST, and bilirubin) per most recent available lab test (within 3 months of screening)
- •3 times institutional upper limit of normal for ALT and AST
- •1.5 times institutional upper limit of normal for bilirubin
- •Have uncontrolled or unmanaged liver disease.
- •Consume more than 6 cups of green tea per day.
- •Have known allergies to caffeine.
- •Be diagnosed with a major psychiatric illness requiring hospitalization within the last year.
- •Be diagnosed with dementia.
- •Cannot provide informed consent due to lack of decision-making capacity (as determined by the patient's oncologist).
研究组 & 干预措施
Epigallocatechin-3-Gallate (EGCG)
800mg Epigallocatechin-3-Gallate (EGCG) pills AND 250mg Ascorbic Acid (Vitamin C) once daily
干预措施: Ascorbic Acid (Vitamin C) (Dietary Supplement)
Microcrystalline cellulose (MCC)
800mg microcrystalline cellulose (MCC) pills AND 250mg Ascorbic Acid (Vitamin C) once daily
干预措施: Ascorbic Acid (Vitamin C) (Dietary Supplement)
Epigallocatechin-3-Gallate (EGCG)
800mg Epigallocatechin-3-Gallate (EGCG) pills AND 250mg Ascorbic Acid (Vitamin C) once daily
干预措施: Epigallocatechin-3-Gallate (EGCG) (Drug)
Microcrystalline cellulose (MCC)
800mg microcrystalline cellulose (MCC) pills AND 250mg Ascorbic Acid (Vitamin C) once daily
干预措施: Microcrystalline cellulose (MCC) (Drug)
结局指标
主要结局
Change of physical frailty measured using the Short Physical Performance Battery (SPPB) in patients in the EGCG arm compared to placebo; change in SPPB scores from baseline to 12 weeks.
时间窗: 12 Weeks
We will assess the change in SPPB scores from baseline to 12 weeks after baseline in patients in the EGCG intervention arm compared to the placebo arm.
次要结局
未报告次要终点
研究者
Nikesha Gilmore
Assistant Professor
University of Rochester