Reducing Frailty for Older Cancer Survivors Using Supplements II

Phase 2

Recruiting

• Conditions: Inflammation; Frailty
• Interventions: Drug: Epigallocatechin-3-Gallate (EGCG); Drug: Microcrystalline cellulose (MCC); Dietary Supplement: Ascorbic Acid (Vitamin C)

• Registration Number: NCT06068543
• Lead Sponsor: University of Rochester

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-20
• Study First Submitted QC: 2023-09-28
• Study First Posted: 2023-10-05
• Study Start: 2024-09-30
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-27
• Last Update Posted: 2025-01-29
• Primary Completion: 2030-01-01
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 118

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 the following endocrine therapies are allowed to enroll (Anastrozole,Leuprolide acetate, and Bicalutamide)
4. Have a Fried's Frailty Score (FFS) of ≥ 1
5. Able to provide informed consent

Exclusion Criteria

1. Have chemotherapy or other systemic cancer treatment planned to occur during the study period.

2. Have abnormal liver function tests (ALT, AST, and bilirubin) per most recent available lab test (within 3 months of screening)

   • 3 times institutional upper limit of normal for ALT and AST
   • 1.5 times institutional upper limit of normal for bilirubin

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Epigallocatechin-3-Gallate (EGCG)	Epigallocatechin-3-Gallate (EGCG)	800mg Epigallocatechin-3-Gallate (EGCG) pills AND 250mg Ascorbic Acid (Vitamin C) once daily
Microcrystalline cellulose (MCC)	Microcrystalline cellulose (MCC)	800mg microcrystalline cellulose (MCC) pills AND 250mg Ascorbic Acid (Vitamin C) once daily
Epigallocatechin-3-Gallate (EGCG)	Ascorbic Acid (Vitamin C)	800mg Epigallocatechin-3-Gallate (EGCG) pills AND 250mg Ascorbic Acid (Vitamin C) once daily
Microcrystalline cellulose (MCC)	Ascorbic Acid (Vitamin C)	800mg microcrystalline cellulose (MCC) pills AND 250mg Ascorbic Acid (Vitamin C) once daily

Primary Outcome Measures

Name	Time	Method
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.	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.

Trial Locations

Locations (1)

University of Rochester; 🇺🇸 Rochester, New York, United States