Reducing Frailty for Older Cancer Survivors Using Supplements (ReFOCUS1)

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

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 Overview

• Status: Completed
• Conditions: Inflammation; Frailty
• Intervention / Treatment: Drug: Epigallocatechin-3-Gallate (EGCG) plus Ascorbic Acid (Vitamin C)

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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 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 guidelines.

Exclusion Criteria: Study subjects must not:

1. Have chemotherapy planned for the during of the study.
2. 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).
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 URCC guidelines.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; Four 200mg EGCG pills and one 250mg Vitamin C pill taken one time each day	Drug: Epigallocatechin-3-Gallate (EGCG) plus Ascorbic Acid (Vitamin C); 800mg Epigallocatechin-3-Gallate (EGCG) plus 250mg Ascorbic Acid (Vitamin C) taken one time a day for twelve weeks; Other Names: EGCG plus Vitamin C
No Intervention: Usual Care Group; No study pills

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment Feasibility: Rates of Consent	Recruitment feasibility will be determined by the proportion of participants approached compared to those consented onto the study.	Baseline
Recruitment Feasibility: Rates of Randomization	Recruitment feasibility will be determined by the proportion of participants consented compared to those randomized into one of the study arms.	Baseline
The Proportion of Participants That Completed the Study	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.	12 week
The Proportion of Participants That Were Adherent to the Intervention	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).	12 week
Safety of the EGCG Intervention	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.	12 weeks

Collaborators and Investigators

• Sponsor: University of Rochester

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2021
• Primary Completion (Actual): August 31, 2023
• Study Completion (Actual): August 31, 2023

Study Registration Dates

• First Submitted: September 4, 2020
• First Submitted That Met QC Criteria: September 11, 2020
• First Posted (Actual): September 17, 2020

Study Record Updates

• Last Update Posted (Actual): May 7, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Frailty; Inflammation; Organic Chemicals; Carbohydrates; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Hydroxy Acids; Ascorbic Acid; epigallocatechin gallate
• Other Study ID Numbers: UCCS20081

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No