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Completed

NCT Number: NCT04553666

Reducing Frailty for Older Cancer Survivors Using Supplements

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

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Key information

Conditions

Frailty Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Rochester

Rochester, New York, 14627, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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.

Treatment and study plan

Epigallocatechin-3-Gallate (EGCG) plus Ascorbic Acid (Vitamin C)

Drug

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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).

  5. 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.

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Registry information

Official study title

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

Acronym: ReFOCUS1

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Sep 17, 2020
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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