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Reducing Frailty for Older Cancer Survivors Using Supplements II

Reducing Frailty for Older Cancer Survivors Using Supplements II

Recruiting
65 years and older
All
Phase 2

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Overview

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.

Eligibility

Inclusion Criteria:

  1. Be age 65 or over.
  2. Be diagnosed with stage I-III Cancer
  3. 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)
  4. Have a Fried's Frailty Score (FFS) of ≥ 1
  5. Able to provide informed consent

Exclusion Criteria:

  1. Have chemotherapy or other systemic cancer treatment planned to occur during the study period.
  2. 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
  3. Have uncontrolled or unmanaged liver disease.
  4. Consume more than 6 cups of green tea per day.
  5. Have known allergies to caffeine.
  6. Be diagnosed with a major psychiatric illness requiring hospitalization within the last year.
  7. Be diagnosed with dementia.
  8. Cannot provide informed consent due to lack of decision-making capacity (as determined by the patient's oncologist).

Study details
    Frailty
    Inflammation

NCT06068543

University of Rochester

15 October 2025

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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