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

April 9, 2024 updated by: Nikesha Gilmore, University of Rochester

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

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

118

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 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 URCC guidelines.

Exclusion Criteria:

  1. Have chemotherapy planned for the duration of the study.
  2. 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).
  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 University of Rochester Cancer Control (URCC) guidelines.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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.
Time Frame: 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

This is where you will find people and organizations involved with this study.

Sponsor

University of Rochester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 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)

April 10, 2024

Last Update Submitted That Met QC Criteria

April 9, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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