Reducing Frailty for Older Cancer Survivors Using Supplements II

Study Overview
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Brief Summary
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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.

Official Title
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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)
* Drug: Microcrystalline cellulose (MCC)
* Dietary Supplement: 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 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.

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-3-Gallate (EGCG) + 250mg Ascorbic Acid
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Epigallocatechin-3-Gallate (EGCG)<br>800mg Epigallocatechin-3-Gallate (EGCG) pills AND 250mg Ascorbic Acid (Vitamin C) once daily | Drug: Epigallocatechin-3-Gallate (EGCG)<br>* 800mg Epigallocatechin-3-Gallate (EGCG)<br>* Other names: EGCG;Dietary Supplement: Ascorbic Acid (Vitamin C)<br>* 250mg Ascorbic Acid (Vitamin C) taken one time daily for 12 weeks<br>* Other names: Vitamin C;|
| Placebo Comparator: Microcrystalline cellulose (MCC)<br>800mg microcrystalline cellulose (MCC) pills AND 250mg Ascorbic Acid (Vitamin C) once daily | Drug: Microcrystalline cellulose (MCC)<br>* 800mg microcrystalline cellulose (MCC)<br>* Other names: MCC;Dietary Supplement: Ascorbic Acid (Vitamin C)<br>* 250mg Ascorbic Acid (Vitamin C) taken one time daily for 12 weeks<br>* Other names: Vitamin C;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 Weeks |