Reducing Frailty for Older Cancer Survivors Using Supplements (ReFOCUS): A Pilot Randomized Controlled Trial of the Feasibility, Safety, and Preliminary Effects of Epigallocatechin-3-Gallate (EGCG) in Pre-Frail and Frail Older Cancer Survivors
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- University of Rochester
- Enrollment
- 24
- Locations
- 2
- Primary Endpoint
- Recruitment Feasibility: Rates of Consent
Study Overview
Brief 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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 ≥
- •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.
Arms & Interventions
Intervention Group
Four 200mg EGCG pills and one 250mg Vitamin C pill taken one time each day
Intervention: Epigallocatechin-3-Gallate (EGCG) plus Ascorbic Acid (Vitamin C) (Drug)
Outcomes
Primary Outcomes
Recruitment Feasibility: Rates of Consent
Time Frame: Baseline
Recruitment feasibility will be determined by the proportion of participants approached compared to those consented onto the study.
Recruitment Feasibility: Rates of Randomization
Time Frame: Baseline
Recruitment feasibility will be determined by the proportion of participants consented compared to those randomized into one of the study arms.
The Proportion of Participants That Completed the Study
Time Frame: 12 week
To determine adherence of a two arm randomized clinical trial of EGCG supplementation in older survivors of cancer by determining how many participants completed the study.The number of participants randomized compared to the number of participants that returned for the post intervention visit.
The Proportion of Participants That Were Adherent to the Intervention
Time Frame: 12 week
To determine adherence of a two arm randomized clinical trial of EGCG supplementation in older survivors of cancer by determining the proportion of participants that were adherent to the intervention (taking \>70% of study drug).
Safety of the EGCG Intervention
Time Frame: 12 weeks
Total (sum) and severity of adverse events (AEs) reported over 12 weeks of being on study graded using CTCAE v5.0 was determined. Participants were called weekly by study coordinator and asked to report concerns including: symptoms, signs, illnesses, or experiences that develop or worsen during the study. These concerns were graded according to the CTCAE v5.0. Number of participants who reported any AEs during the 12 weeks of the study are reported.
Secondary Outcomes
No secondary outcomes reported
Investigators
Nikesha Gilmore
Assistant Professor
University of Rochester