Back to resultsReducing Frailty for Older Cancer Survivors Using Supplements (ReFOCUS)
Primary Purpose
Frailty, Inflammation
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Epigallocatechin-3-Gallate (EGCG) plus Ascorbic Acid (Vitamin C)
Sponsored by
About this trial
This is an interventional supportive care trial for Frailty
Eligibility Criteria
Inclusion Criteria:
- Be age 65 or over.
- Be diagnosed with stage I-III Cancer.
- Have completed curative intent treatment ≤12 months 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.
Sites / Locations
- University of Rochester
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention Group
Usual Care Group
Arm Description
Four 200mg EGCG pills and one 250mg Vitamin C pill taken one time each day
No study pills
Outcomes
Primary Outcome Measures
To determine the recruitment feasibility of conducting a two arm randomized clinical trial of EGCG supplementation in older survivors of cancer
Recruitment feasibility will be measured by the rates of recruitment at the baseline time-point.
To determine adherence of a two arm randomized clinical trial of EGCG supplementation in older survivors of cancer
The proportion of subjects that adhered to study procedures and the EGCG intervention at the 12 week time-point.
Secondary Outcome Measures
Full Information
NCT ID
NCT04553666
First Posted
September 4, 2020
Last Updated
September 19, 2023
Sponsor
University of Rochester
1. Study Identification
Unique Protocol Identification Number
NCT04553666
Brief Title
Reducing Frailty for Older Cancer Survivors Using Supplements
Acronym
ReFOCUS
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
March 15, 2021 (Actual)
Primary Completion Date
August 31, 2023 (Actual)
Study Completion Date
August 31, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frailty, Inflammation
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Patients in the intervention Arm will receive 800 mg Epigallocatechin gallate (EGCG) + 250mg Ascorbic Acid
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Four 200mg EGCG pills and one 250mg Vitamin C pill taken one time each day
Arm Title
Usual Care Group
Arm Type
No Intervention
Arm Description
No study pills
Intervention Type
Drug
Intervention Name(s)
Epigallocatechin-3-Gallate (EGCG) plus Ascorbic Acid (Vitamin C)
Other Intervention Name(s)
EGCG plus Vitamin C
Intervention Description
800mg Epigallocatechin-3-Gallate (EGCG) plus 250mg Ascorbic Acid (Vitamin C) taken one time a day for twelve weeks
Primary Outcome Measure Information:
Title
To determine the recruitment feasibility of conducting a two arm randomized clinical trial of EGCG supplementation in older survivors of cancer
Description
Recruitment feasibility will be measured by the rates of recruitment at the baseline time-point.
Time Frame
Baseline
Title
To determine adherence of a two arm randomized clinical trial of EGCG supplementation in older survivors of cancer
Description
The proportion of subjects that adhered to study procedures and the EGCG intervention at the 12 week time-point.
Time Frame
12 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14627
Country
United States
12. IPD Sharing Statement
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Reducing Frailty for Older Cancer Survivors Using Supplements
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