Reducing Frailty for Older Cancer Survivors Using Supplements (ReFOCUS): A Pilot Randomized Controlled Trial of the Feasibility, Safety, and Preliminary Effects of Epigallocatechin-3-Gallate (EGCG) in Pre-Frail and Frail Older Cancer Survivors
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Recruitment Feasibility: Rates of Consent
研究概览
简要总结
The purpose of the study is to examine the feasibility and safety of twelve weeks oral supplementation of Epigallocatechin-3-gallate (EGCG) in older survivors of cancer
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
- 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 endocrine therapies are allowed to enroll.)
- •Have a Fried's Frailty Score (FFS) of ≥
- •Able to provide informed consent, or have consent given by patient-designated health care proxy per institutional policies and University of Rochester Cancer Control guidelines.
排除标准
- •Study subjects must not:
- •Have chemotherapy planned for the during of the study.
- •Have abnormal liver function tests (ALT, AST and bilirubin ≥3 times institutional upper limit of normal) per most recent available lab test (within 3 months of screening).
- •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) and has no patient-designated health care proxy per institutional policies and University of Rochester Cancer Control URCC guidelines.
研究组 & 干预措施
Intervention Group
Four 200mg EGCG pills and one 250mg Vitamin C pill taken one time each day
干预措施: Epigallocatechin-3-Gallate (EGCG) plus Ascorbic Acid (Vitamin C) (Drug)
结局指标
主要结局
Recruitment Feasibility: Rates of Consent
时间窗: Baseline
Recruitment feasibility will be determined by the proportion of participants approached compared to those consented onto the study.
Recruitment Feasibility: Rates of Randomization
时间窗: Baseline
Recruitment feasibility will be determined by the proportion of participants consented compared to those randomized into one of the study arms.
The Proportion of Participants That Completed the Study
时间窗: 12 week
To determine adherence of a two arm randomized clinical trial of EGCG supplementation in older survivors of cancer by determining how many participants completed the study.The number of participants randomized compared to the number of participants that returned for the post intervention visit.
The Proportion of Participants That Were Adherent to the Intervention
时间窗: 12 week
To determine adherence of a two arm randomized clinical trial of EGCG supplementation in older survivors of cancer by determining the proportion of participants that were adherent to the intervention (taking \>70% of study drug).
Safety of the EGCG Intervention
时间窗: 12 weeks
Total (sum) and severity of adverse events (AEs) reported over 12 weeks of being on study graded using CTCAE v5.0 was determined. Participants were called weekly by study coordinator and asked to report concerns including: symptoms, signs, illnesses, or experiences that develop or worsen during the study. These concerns were graded according to the CTCAE v5.0. Number of participants who reported any AEs during the 12 weeks of the study are reported.
次要结局
未报告次要终点
研究者
Nikesha Gilmore
Assistant Professor
University of Rochester