Reducing Frailty for Older Cancer Survivors Using Supplements II (ReFOCUS2)
Frailty, Inflammation
About this trial
This is an interventional supportive care trial for Frailty
Eligibility 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 URCC guidelines. Exclusion Criteria: Have chemotherapy planned for the duration of the study. 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). 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 University of Rochester Cancer Control (URCC) guidelines.
Sites / Locations
- University of Rochester
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Epigallocatechin-3-Gallate (EGCG)
Microcrystalline cellulose (MCC)
800mg Epigallocatechin-3-Gallate (EGCG) pills AND 250mg Ascorbic Acid (Vitamin C) once daily
800mg microcrystalline cellulose (MCC) pills AND 250mg Ascorbic Acid (Vitamin C) once daily