Reducing Frailty for Older Cancer Survivors Using Supplements (ReFOCUS)

University of Rochester

Status and phase

Completed

Phase 2

Conditions

Inflammation

Frailty

Treatments

Drug: Epigallocatechin-3-Gallate (EGCG) plus Ascorbic Acid (Vitamin C)

Study type

Interventional

Funder types

Other

Identifiers

NCT04553666

UCCS20081

Details and patient eligibility

About

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

Enrollment

24 patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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: 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.