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ReFOCUS: Reducing Frailty for Older Cancer Survivors Using Supplements

Sponsor
University of Rochester (Other)
Overall Status
Recruiting
CT.gov ID
NCT04553666
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
33.5
Anticipated Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Epigallocatechin-3-Gallate (EGCG) plus Ascorbic Acid (Vitamin C)
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Patients in the intervention Arm will receive 800 mg Epigallocatechin gallate (EGCG) + 250mg Ascorbic AcidPatients in the intervention Arm will receive 800 mg Epigallocatechin gallate (EGCG) + 250mg Ascorbic Acid
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Reducing Frailty for Older Cancer Survivors Using Supplements (ReFOCUS): A Phase 2 Randomized Controlled Trial of Epigallocatechin-3-Gallate (EGCG) on Frailty and Inflammation in Older Survivors of Cancer
Actual Study Start Date :
Mar 15, 2021
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. To determine the recruitment feasibility of conducting a two arm randomized clinical trial of EGCG supplementation in older survivors of cancer [Baseline]

      Recruitment feasibility will be measured by the rates of recruitment at the baseline time-point.

    2. To determine adherence of a two arm randomized clinical trial of EGCG supplementation in older survivors of cancer [12 week]

      The proportion of subjects that adhered to study procedures and the EGCG intervention at the 12 week time-point.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Be age 65 or over.

    2. Be diagnosed with stage I-III Cancer.

    3. Have completed curative intent treatment ≤12 months 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Rochester Rochester New York United States 14627

    Sponsors and Collaborators

    • University of Rochester

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nikesha Gilmore, Assistant Professor, University of Rochester
    ClinicalTrials.gov Identifier:
    NCT04553666
    Other Study ID Numbers:
    • UCCS20081
    First Posted:
    Sep 17, 2020
    Last Update Posted:
    Aug 16, 2022
    Last Verified:
    Aug 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Inflammation
    Frailty
    Vitamins
    Ascorbic Acid
    Epigallocatechin gallate

    Study Results

    No Results Posted as of Aug 16, 2022