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

Primary Purpose

Frailty, Inflammation

Status
Not yet recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Epigallocatechin-3-Gallate (EGCG)
Microcrystalline cellulose (MCC)
Ascorbic Acid (Vitamin C)
Sponsored by
University of Rochester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Frailty

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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 URCC guidelines. Exclusion Criteria: Have chemotherapy planned for the duration of the study. 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). 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 University of Rochester Cancer Control (URCC) guidelines.

Sites / Locations

  • University of Rochester

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Epigallocatechin-3-Gallate (EGCG)

Microcrystalline cellulose (MCC)

Arm Description

800mg Epigallocatechin-3-Gallate (EGCG) pills AND 250mg Ascorbic Acid (Vitamin C) once daily

800mg microcrystalline cellulose (MCC) pills AND 250mg Ascorbic Acid (Vitamin C) once daily

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 20, 2023
Last Updated
September 28, 2023
Sponsor
University of Rochester
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1. Study Identification

Unique Protocol Identification Number
NCT06068543
Brief Title
Reducing Frailty for Older Cancer Survivors Using Supplements II
Acronym
ReFOCUS2
Official Title
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
Not yet recruiting
Study Start Date
January 1, 2024 (Anticipated)
Primary Completion Date
January 1, 2030 (Anticipated)
Study Completion Date
December 31, 2030 (Anticipated)

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
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.

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-3-Gallate (EGCG) + 250mg Ascorbic Acid
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
118 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Epigallocatechin-3-Gallate (EGCG)
Arm Type
Experimental
Arm Description
800mg Epigallocatechin-3-Gallate (EGCG) pills AND 250mg Ascorbic Acid (Vitamin C) once daily
Arm Title
Microcrystalline cellulose (MCC)
Arm Type
Placebo Comparator
Arm Description
800mg microcrystalline cellulose (MCC) pills AND 250mg Ascorbic Acid (Vitamin C) once daily
Intervention Type
Drug
Intervention Name(s)
Epigallocatechin-3-Gallate (EGCG)
Other Intervention Name(s)
EGCG
Intervention Description
800mg Epigallocatechin-3-Gallate (EGCG)
Intervention Type
Drug
Intervention Name(s)
Microcrystalline cellulose (MCC)
Other Intervention Name(s)
MCC
Intervention Description
800mg microcrystalline cellulose (MCC)
Intervention Type
Dietary Supplement
Intervention Name(s)
Ascorbic Acid (Vitamin C)
Other Intervention Name(s)
Vitamin C
Intervention Description
250mg Ascorbic Acid (Vitamin C) taken one time daily for 12 weeks
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
12 Weeks

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 URCC guidelines. Exclusion Criteria: Have chemotherapy planned for the duration of the study. 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). 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 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 II

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