Reducing Frailty for Older Cancer Survivors Using Supplements II (ReFOCUS2)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Inflammation; Frailty
• Intervention / Treatment: Drug: Epigallocatechin-3-Gallate (EGCG); Dietary supplement: Ascorbic Acid (Vitamin C); Drug: Microcrystalline cellulose (MCC)

• Study Type: Interventional
• Enrollment (Estimated): 118
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14627
      • Recruiting
      • University of Rochester
      • Contact: Nikesha Gilmore, PhD; Phone Number: 5852751275; Email: nikesha_gilmore@urmc.rochester.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 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 the following endocrine therapies are allowed to enroll (Anastrozole,Leuprolide acetate, and Bicalutamide)
4. Have a Fried's Frailty Score (FFS) of ≥ 1
5. Able to provide informed consent

Exclusion Criteria:

1. Have chemotherapy or other systemic cancer treatment planned to occur during the study period.

2. Have abnormal liver function tests (ALT, AST, and bilirubin) per most recent available lab test (within 3 months of screening)

   • 3 times institutional upper limit of normal for ALT and AST
   • 1.5 times institutional upper limit of normal for bilirubin
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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Epigallocatechin-3-Gallate (EGCG); 800mg Epigallocatechin-3-Gallate (EGCG) pills AND 250mg Ascorbic Acid (Vitamin C) once daily	Drug: Epigallocatechin-3-Gallate (EGCG); 800mg Epigallocatechin-3-Gallate (EGCG); Other Names: EGCG; Dietary supplement: Ascorbic Acid (Vitamin C); 250mg Ascorbic Acid (Vitamin C) taken one time daily for 12 weeks; Other Names: Vitamin C
Placebo Comparator: Microcrystalline cellulose (MCC); 800mg microcrystalline cellulose (MCC) pills AND 250mg Ascorbic Acid (Vitamin C) once daily	Dietary supplement: Ascorbic Acid (Vitamin C); 250mg Ascorbic Acid (Vitamin C) taken one time daily for 12 weeks; Other Names: Vitamin C; Drug: Microcrystalline cellulose (MCC); 800mg microcrystalline cellulose (MCC); Other Names: MCC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of physical frailty measured using the Short Physical Performance Battery (SPPB) in patients in the EGCG arm compared to placebo; change in SPPB scores from baseline to 12 weeks.	We will assess the change in SPPB scores from baseline to 12 weeks after baseline in patients in the EGCG intervention arm compared to the placebo arm.	12 Weeks

Collaborators and Investigators

• Sponsor: University of Rochester

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2024
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: September 20, 2023
• First Submitted That Met QC Criteria: September 28, 2023
• First Posted (Actual): October 5, 2023

Study Record Updates

• Last Update Posted (Actual): March 6, 2026
• Last Update Submitted That Met QC Criteria: March 4, 2026
• Last Verified: March 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; microcrystalline cellulose
• Other Study ID Numbers: UOCPC23048

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No