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Epigallocatechin-3-Gallate (EGCG) plus Ascorbic Acid (Vitamin C) for Frailty (ReFOCUS Trial)
ReFOCUS Trial Summary
This trial will test if it is safe for cancer survivors to take EGCG supplements for twelve weeks.
- Frailty
- Inflammation
ReFOCUS Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.ReFOCUS Trial Design
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Who is running the clinical trial?
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- You were hospitalized for a major mental illness in the past year.You have been diagnosed with a type of memory loss called dementia.You drink more than 6 cups of green tea each day.You are allergic to caffeine.You are going to receive chemotherapy during the study period.You have a high level of frailty, as measured by the Fried's Frailty Score (FFS) of 2 or greater.
- Group 1: Intervention Group
- Group 2: Usual Care Group
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What is the current sample size of participants involved in this research?
"Affirmative, clinicaltrials.gov indicates that this research project is actively recruiting participants. It was initially posted on March 15th 2021 and recently updated on August 15th 2022; the study hopes to recruit 40 individuals from one location."
To what ailments are EGCG and Vitamin C most often applied as a remedy?
"Deficiencies in Vitamin A can be remedied with a combination of Epigallocatechin-3-Gallate (EGCG) and Ascorbic Acid (Vitamin C). This same prescription may also benefit patients who suffer from catarrh, vitamin deficiency, or require additional supplementation."
Are individuals currently able to participate in this research endeavor?
"Affirmative. According to clinicaltrials.gov, this trial is actively looking for participants and was initially posted on March 15th 2021 with the most recent update appearing August 15th 2022. It requires a total of 40 individuals based out of 1 medical facility."
Has the FDA sanctioned the use of Epigallocatechin-3-Gallate combined with Ascorbic Acid?
"Although no prior data indicates its efficacy, the safety of Epigallocatechin-3-Gallate (EGCG) plus Ascorbic Acid (Vitamin C) has been supported in a Phase 2 trial. Thus, our team at Power estimated it to be a level 2 on their scale."
What are the fundamental endeavors of this clinical experiment?
"This 12 week monitored trial will primarily assess the recruitment feasibility of conducting a two arm randomized clinical trial with EGCG supplementation in elderly colon cancer survivors. Additionally, secondary objectives include evaluating changes to circulating immune cells, Deficit Accumulation Frailty Index (DAFI) and Fried's Frailty Score from baseline to the end of this medical study."
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