Reducing Frailty for Older Cancer Survivors Using Supplements

University of Rochester24 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Frailty Inflammation

Interventions

Epigallocatechin-3-Gallate (EGCG) plus Ascorbic Acid (Vitamin C)DRUG

800mg Epigallocatechin-3-Gallate (EGCG) plus 250mg Ascorbic Acid (Vitamin C) taken one time a day for twelve weeks

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Be age 65 or over. 2. Be diagnosed with stage I-III Cancer. 3. Have completed curative intent treatment ≤10 years 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.

Locations (1)

University of Rochester

Rochester, New York, United States

Outcomes

Primary Outcomes

Recruitment Feasibility: Rates of Consent

Recruitment feasibility will be determined by the proportion of participants approached compared to those consented onto the study.

Time frame: Baseline

Recruitment Feasibility: Rates of Randomization

Recruitment feasibility will be determined by the proportion of participants consented compared to those randomized into one of the study arms.

Time frame: Baseline

The Proportion of Participants That Completed the Study

To determine adherence of a two arm randomized clinical trial of EGCG supplementation in older survivors of cancer by determining how many participants completed the study.The number of participants randomized compared to the number of participants that returned for the post intervention visit.

Time frame: 12 week

The Proportion of Participants That Were Adherent to the Intervention

To determine adherence of a two arm randomized clinical trial of EGCG supplementation in older survivors of cancer by determining the proportion of participants that were adherent to the intervention (taking \>70% of study drug).

Time frame: 12 week

Safety of the EGCG Intervention

Total (sum) and severity of adverse events (AEs) reported over 12 weeks of being on study graded using CTCAE v5.0 was determined. Participants were called weekly by study coordinator and asked to report concerns including: symptoms, signs, illnesses, or experiences that develop or worsen during the study. These concerns were graded according to the CTCAE v5.0. Number of participants who reported any AEs during the 12 weeks of the study are reported.

Time frame: 12 weeks

Data from ClinicalTrials.gov

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