Reducing Frailty for Older Cancer Survivors Using Supplements II

Description

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.

Conditions

Frailty, Inflammation

Study Overview

Study Details

Study 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.

A Phase 2 Randomized Controlled Trial of Epigallocatechin-3-Gallate (EGCG) on Frailty and Inflammation in Older Survivors of Cancer

Reducing Frailty for Older Cancer Survivors Using Supplements II

Condition
Frailty
Intervention / Treatment

-

Contacts and Locations

Rochester

University of Rochester, Rochester, New York, United States, 14627

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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 endocrine therapies are allowed to enroll)
  • 4. Have a Fried's Frailty Score (FFS) of ≥ 2
  • 5. Able to provide informed consent, or have consent given by patient-designated health care proxy per institutional policies and University of Rochester Cancer Control URCC guidelines.
  • 1. Have chemotherapy planned for the duration of the study.
  • 2. Have abnormal liver function tests (Alanine transaminase (ALT), Aspartate transaminase (AST), and bilirubin ≥ 3 times institutional upper limit of normal) per most recent available lab test (within 3 months of screening).
  • 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) and has no patient-designated health care proxy per institutional policies and University of Rochester Cancer Control University of Rochester Cancer Control (URCC) guidelines.

Ages Eligible for Study

65 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Rochester,

Study Record Dates

2030-12-31