Reducing Frailty for Older Cancer Survivors Using Supplements (NCT04553666) | Clinical Trial Compass
CompletedPhase 2
Reducing Frailty for Older Cancer Survivors Using Supplements
United States24 participantsStarted 2021-04-28
Plain-language summary
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
Who can participate
Age range
65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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 ≥ 2.
. 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.
Exclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Recruitment Feasibility: Rates of Consent
Timeframe: Baseline
2
Recruitment Feasibility: Rates of Randomization
Timeframe: Baseline
3
The Proportion of Participants That Completed the Study
Timeframe: 12 week
4
The Proportion of Participants That Were Adherent to the Intervention
. 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.