Reducing Frailty for Older Cancer Survivors Using Supplements II

NCT06068543 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: UOCPC23048
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

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.

Conditions

Frailty; Inflammation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Epigallocatechin-3-Gallate (EGCG)

EXPERIMENTAL

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

Drug: Epigallocatechin-3-Gallate (EGCG); Dietary Supplement: Ascorbic Acid (Vitamin C)

Microcrystalline cellulose (MCC)

PLACEBO COMPARATOR

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

Drug: Microcrystalline cellulose (MCC); Dietary Supplement: Ascorbic Acid (Vitamin C)

Interventions

Epigallocatechin-3-Gallate (EGCG) DRUG

800mg Epigallocatechin-3-Gallate (EGCG)

Also known as: EGCG

Epigallocatechin-3-Gallate (EGCG)

Microcrystalline cellulose (MCC) DRUG

800mg microcrystalline cellulose (MCC)

Also known as: MCC

Microcrystalline cellulose (MCC)

Ascorbic Acid (Vitamin C) DIETARY_SUPPLEMENT

250mg Ascorbic Acid (Vitamin C) taken one time daily for 12 weeks

Also known as: Vitamin C

Epigallocatechin-3-Gallate (EGCG); Microcrystalline cellulose (MCC)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Be age 65 or over.
• Be diagnosed with stage I-III Cancer
• Have completed curative intent treatment ≤10 years prior to screening Patients on the following endocrine therapies are allowed to enroll (Anastrozole,Leuprolide acetate, and Bicalutamide)
• Have a Fried's Frailty Score (FFS) of ≥ 1
• Able to provide informed consent

You may not qualify if:

• Have chemotherapy or other systemic cancer treatment planned to occur during the study period.
• Have abnormal liver function tests (ALT, AST, and bilirubin) per most recent available lab test (within 3 months of screening)
• times institutional upper limit of normal for ALT and AST
• times institutional upper limit of normal for bilirubin
• 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).

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

University of Rochester

Rochester, New York, 14627, United States

RECRUITING

MeSH Terms

Conditions

Frailty; Inflammation

Interventions

epigallocatechin gallate; microcrystalline cellulose; Ascorbic Acid

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Patients in the intervention Arm will receive 800 mg Epigallocatechin-3-Gallate (EGCG) + 250mg Ascorbic Acid

Study Record Dates

• First Submitted: September 20, 2023
• First Posted: October 5, 2023
• Study Start: October 25, 2024
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: March 6, 2026

Record last verified: 2026-03

Locations

US (1)