Reducing Frailty for Older Cancer Survivors Using Supplements

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Frailty, Inflammation

Intervention / Treatment
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* Drug: Epigallocatechin-3-Gallate (EGCG) plus Ascorbic Acid (Vitamin C)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients in the intervention Arm will receive 800 mg Epigallocatechin gallate (EGCG) + 250mg Ascorbic Acid
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>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)<br>* 800mg Epigallocatechin-3-Gallate (EGCG) plus 250mg Ascorbic Acid (Vitamin C) taken one time a day for twelve weeks<br>* Other names: EGCG plus Vitamin C;|
| No Intervention: Usual Care Group<br>No study pills | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline | 
| 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. | 12 week |